A Phase 4 interventional study of Corifollitropin alfa in Infertility, sponsored by IVI Madrid. Terminated. Open to female participants aged 18 Years to 37 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by IVI Madrid · Phase 4, Interventional, and Treatment
The study is proposed to determine the effect of three types of gonadotropins that are currently used in protocols of controlled ovarian stimulation in women undergoing in vitro fertilization techniques on the kinetics of embryonic development.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's enrollment of 201 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →IVI Madrid is the lead sponsor of 35 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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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.
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.
Under current practice, 67 participants will be stimulated with a single injection of 100 mg, sc of Corifollitropin alpha (Elonva®). From day 6 stimulation and even prior to induction of ovulation day, 0.25 mg / day was administered sc ganirelix (Orgalutran®). From day 8 stimulation and depending on the ovarian response, you can add recombinant FSH (Puregon) up to 150 IU by Puregon Pen® device. In the presence of 3 or more follicles ≥17 mm, ovulation is induced with a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) if there is no risk of OHSS, and 36 hours later he held the follicular puncture oocyte retrieval.
Drug: Corifollitropin alfa
Under current practice, 67 participants will be stimulated with a daily dose of recombinant FSH. Administration of recombinant FSH (Puregon) starts at an initial dose of 150-225 IU / day by the Puregon Pen® device. From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of recombinant FSH according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg or Decapeptyl hCG 6500u (Ovitrelle) is given if there is no risk of OHSS, and 36 hours then held follicular puncture for recovering oocytes.
Drug: Corifollitropin alfa
Under current practice, 67 participants will be stimulated with HP-hMG, following the same pattern described for the group of recombinant FSH. In this case, the initial dose is 225-300 IU / day of HP-hMG (Menopur®). From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of HP-hMG according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) is given if there is no risk of OHSS and 36 hours then held the follicular puncture for oocyte retrieval .
Drug: Corifollitropin alfa
Also known as: Elonva
T5 defined as the time that embryo needs to reach a 5-cell stage.
Time frame: Baseline
Length of stimulation (days)
Time frame: a month
Total dose of gonadotropins (IU)
Time frame: A month
Levels of FSH (IU) Levels of estradiol (pg / ml) - Levels of progesterone (ng / ml) - Fertilization rate - Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation
Time frame: A month
Levels of estradiol (pg / ml) Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation
Time frame: A month
Levels of progesterone (ng/ml)
Time frame: A month
Fertilization rate
Time frame: A month
Number of embryos transferred and cryopreserved
Time frame: A month
Pregnancy rate
Time frame: A month
Implantation rate
Time frame: A monthe
Miscarriage rate
Time frame: A month
Cancellation rate per cycle initiated
Time frame: A month
Ovarian hyperstimulation syndrome rate
Time frame: A month
Timings of cellular divisions
Time frame: A month
No study locations are listed for this record.
Ran from Apr 2015 to primary completion in Sep 2015, 5 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Corifollitropin alfa
IVI Madrid