A Phase 1/2 interventional study of Human Chorionic Gonadotropin (hCG) and Gonadotropins in Female Infertility, Female Infertility Due to Ovulatory Disorder and Premature Ovarian Failure, sponsored by Lebanese University. Completed at 1 site in Lebanon. Open to female participants aged 21 Years to 44 Years. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Lebanese University · Phase 1/2, Interventional, and Health services research
The study will describe the effectiveness of ovarian stimulation in correlation with female infertility causes in a Lebanese population: a comparative study using 5 protocols of ovulation induction (treatment with "A" gonadotropins alone, "B" short GnRH agonist, "C" multiple-dose GnRH antagonist, "D" long GnRH agonist and "E" combined protocol of GnRH antagonist and agonist) and the outcomes of ICSI. This comparative study will help clinicians to select the relevant protocol of ovarian stimulation related to the female infertility disorders.
One in six couples worldwide is affected by infertility, which defined as the inability to conceive after one year or more of regular and unprotected intercourse. It has been stated that 48.5 million couples in the world, with unprotected coitus, suffer from infertility. In about 50% of them, the infertility is due to female factors and diseases associated with the female reproductive system. Epidemiological studies show that 10 to 15% of all married couples are estimated to have infertility problems in the Middle East. Lebanon, in particular, is characterized with traditional and westernized lifestyles; It has high rates of smoking and caffeine intake, pollution and high rates of consanguinity marriage (11 to 17%), which affect considerably the conception rate.
The desire to procreate is naturally present in women all over the world. Due to various advances in medical procreation techniques, it has become possible for many women to realize their hope. Women were more likely to be psychologically distressed to infertility and suffer from poor quality of life more than men once they are diagnosed as infertile.
The causes of female infertility can have a genetic, anatomical or physiological origin. Among the most common genetic causes of female infertility are the chromosomes abnormalities: the numbers of X chromosomes, homogeneous or mosaic; other abnormalities are reciprocal translocations, Robertsonian translocations, inversions, supernumerary markers or abnormalities of the X chromosome structure. In such cases, no treatment and procreation require an egg donation. But the main causes of female infertility are physiological and anatomical, such as ovulatory disorders (25%), endometriosis (15%), pelvic adhesions (12%), tubal blockage (11%), other tubal abnormalities (11%), hyperprolactinemia (7%) and some minor causes. In addition, leiomyomas, fibroma, polyps, and tubal disease, may reduce fertility. In addition came the environmental factors (drugs, pesticides, food, tobacco ...) and there is an increase in the percentage of infertile women with advancing female age. A French national survey on lifestyles and toxic factors in infertile couples showed that in women, tobacco generates a risk twice as high as being infertile, a decrease in the ovarian reserve where the level of anti-Mullerian hormone (AMH) decreases, irregular short cycles and dysmenorrhea are also found in smokers. In addition, products contained in tobacco such as cotinine, cadmium and hydrogen peroxide are found in the follicular fluid and would be responsible for an alteration of the recovery of oocyte meiosis.
Couples who have problems with conception are referred to a medically assisted procreation (MAP) for fertility treatments. These treatments can be very stressful both psychologically and physically. Indeed, the numerous medical appointments and examinations, as well as the many bereavements and failures, experienced following repeated attempts at conception can to consume the married, social and professional life of couples. In addition, fertility issues require significant financial resources to cover the costs of fertility treatments, but also those related to the maternal and fetal complications of pregnancy, which are more frequent in the case of MAP pregnancies than in spontaneous conception.
Control of the ovarian stimulation is the key component of assisted reproductive technologies (ART) that have shifted the clinical practice of natural mono-follicular cycles into multi-follicular stimulated cycles. The increase in the number of follicles, and consequently the number of oocytes recovered, improved pregnancy rates in women undergoing In Vitro Fertilization (IVF) / Intra-Cytoplasmic Sperm Injection (ICSI), not only by increasing the number of available embryos but also by allowing embryo culture extended and allowing the selection of higher quality embryos to be transferred. However, several studies have addressed the issue of the optimal number of oocytes recovered following controlled ovarian stimulation (COS) for IVF / ICSI and demonstrated that the ovarian response is independently related to Live Birth Rate (LBR) after IVF / ICSI.
Many new treatment modalities for ovarian stimulation have been introduced over the years - often with insufficient evidence of safety and efficacy - using different compounds and regimens for ovarian stimulation, triggering oocyte maturation, interventions preceding stimulation supplementation phase. The most important clinical challenge is to find the right balance between improving the chances of success (birth of a healthy child), a reasonable cost, acceptable discomfort for the patient, and a minimal complication rate. New developments make ovarian stimulation less intense and more individualized. The choice of the ovarian stimulation protocol is one of the most important steps in IVF/ICSI treatment.
This study aims to identify and evaluate ovarian stimulation protocols applied to different patients with different causes of female infertility prior to medically assisted procreation techniques in order to know if there is a relationship between a given protocol and the result obtained for each class of infertility. Therefore, 360 ICSI in 200-300 couples will be studied in order to evaluate the link between ovarian stimulation protocols and outcomes of ICSI.
The population will be divided into 3 groups:
552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.
This study's enrollment of 200 is above the median of 100 across 378 interventional studies indexed under Infertility, Female.
Browse Infertility, Female studies →Lebanese University is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Protocol with gonadotropins alone without agonist or antagonist: Gonadotropin treatment begins after spontaneous menses. The gonadotropins (e.g. Menopur, 150-225IU) are injected daily from D2/3 of the cycle (Gonadotropin dose varies based on the follicular response). The moment to trigger ovulation by administration of HCG (e.g. Ovitrelle or Pregnyl, 10.000IU) is determined by monitoring ovulation (folliculogenesis) approximately 14 days after gonadotropins regimen and the presence of at least 3 follicles with 18 mm sizes and at least the levels of E2 reaches 250-300 pg/ml. 36 h after HCG triggering, the mature oocytes are retrieved.
Drug: Human Chorionic Gonadotropin (hCG) · Drug: Gonadotropins
Short GnRH agonist protocol: For the short GnRH agonist protocol, the administration of gonadotropins begins at the same time as that of the agonist, which makes it possible to take advantage of the action of endogenous gonadotropins released by the flare-up effect of the agonist. A low dose of GnRH agonist (e.g., triptorelin (Decapeptyl 0.1mg/day)) is administered in parallel to gonadotropin (e.g. Menopur, 150-225 IU) daily starting on cycle-day 2 (Gonadotropin dose varies based on the follicular development). Continual administration of GnRH agonist and gonadotropin lasts until HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU), \~14 days post GnRH agonist regimen when follicles size reached 16-18 mm and at least the levels of E2 reaches 250-300 pg/ml. 36 h after HCG triggering, the mature oocytes are retrieved.
Drug: Human Chorionic Gonadotropin (hCG) · Drug: Gonadotropins · Drug: GNRH-A Triptorelin
Multiple-dose antagonist protocol: For the GnRH antagonist protocol, a low dose of GnRH antagonist (0.25 mg/day) is administered. The protocol starts with the administration of gonadotropin (e.g. Menopur, 150-225 IU) daily which is initiated after monitoring of patients' follicles sizes on cycle-day 2/3 (Gonadotropin dose varies based on the follicular response). Almost after the 6th days of gonadotropin injection or when follicular size reaches more than or equal to 14 mm, GnRH antagonist (e.g., cetrorelix (cetrotide) or ganirelix (orgulatron) 0.25mg) begins by subcutaneous administration every day till HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU). 36 h after HCG triggering, the mature oocytes are retrieved.
Drug: Human Chorionic Gonadotropin (hCG) · Drug: Gonadotropins · Drug: GnRH antagonist
Long GnRH agonist protocol: For the long GnRH agonist protocol, a low dose of GnRH agonist (e.g., triptorelin (Decapeptyl 0.1mg)) is administered on cycle-day 21 followed by gonadotropin (e.g. Menopur, 150-225 IU) daily starting on cycle-day 2 after menses (Gonadotropin dose varies based on the follicular development). Continual administration of GnRH agonist and gonadotropin lasts until HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU), \~14 days post GnRH agonist regimen when follicles size reached 16-18 mm. 36 h after HCG triggering, the mature oocytes are retrieved.
Drug: Human Chorionic Gonadotropin (hCG) · Drug: Gonadotropins · Drug: GNRH-A Triptorelin
Combined GnRH antagonist and agonist protocol: For the combined protocol, it starts with the administration of gonadotropin (e.g. Menopur, 150-225 IU) daily which is initiated after monitoring of patients' follicles sizes on cycle-day 2/3 (Gonadotropin dose varies based on the follicular response). Almost after the 6th days of gonadotropin injection or when follicular size reaches more than or equal to 14 mm, GnRH antagonist (e.g., cetrorelix (cetrotide) or ganirelix (orgulatron) 0.25mg) begins by subcutaneous administration every day till GnRH agonist injection (e.g., triptorelin (Decapeptyl 0.1mg/day)). 36 h after agonist injection, the mature oocytes are retrieved.
Drug: Gonadotropins · Drug: GNRH-A Triptorelin · Drug: GnRH antagonist
Administration of hCG (10.000IU) for ovulation triggering
Also known as: OVITRELLE / PREGNYL
Administration of Menotropin (hMG / FSH and LH at a 1:1 ratio) (150-225IU/day)
Also known as: MENOPUR
Administration of Triptorelin (0.1mg/day)
Also known as: DECAPEPTYL
Administration of cetrorelix (cetrotide) or ganirelix (orgulatron) (0.25mg/day)
Also known as: CETROTIDE / ORGULATRON
Ovulation Induction
Monitoring of Ovulation Stimulation by trans-vaginal ultrasound determining the growth, number and appearance of the ovarian follicles as well as the maturation of the endometrium (measurement of its thickness); Follicles are considered mature when their diameter is greater than 18-20mm and each of them provides 250-300pg/mL of E2. When these criteria are obtained, ovulation is triggered
Time frame: 36 hours
fertilization rate
Changes in the fertilization rate
Time frame: 12 months
embryo quality
Selection of embryos for transfer depending on their morphology, and the regularity of blastomers
Time frame: 12 months
pregnancy rate
Determination of βHCG for positive results
Time frame: 12 months
live birth rate
Calculations of live birth rate are based on the number of live births in each group divided by all live births, multiplied by 100
Time frame: 12 months
Plan to share: No
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Ran from Feb 2018 to primary completion in Aug 2019, 18 months.
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Chorionic Gonadotropin · Triptorelin · Gonadotropin Releasing Hormone Antagonist
Lebanese University