A Phase 2 interventional study of Follitropin Delta, Recombinant in IVF, sponsored by IVI Madrid. Completed at 1 site in Spain. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-14.
Sponsored by IVI Madrid · Phase 2, Interventional, and Treatment
Higher numbers of oocytes have not been shown to increase implantation or live newborn rates, but higher numbers of oocytes are likely to be beneficial in certain treatments. These clinical cases where a high ovarian response can be IVF cycles with genetic diagnosis, patients who need more than one pregnancy or, as in our case, oocyte donation. For this reason, and based on previous studies, investigators intend to increase the ovarian response by increasing the dose of follitropin. This clinical trial aims to evaluate high doses of Rekovelle (follitropin delta) to obtain an average of 17 oocytes in a population of oocyte donors, without affecting the health of the patients.
IVF ovarian stimulation cycles has been shown that the individualization of the medication doses provides clinical results comparable to conventional ovarian stimulation regimens, but also it results in greater treatment safety by significantly reducing the percentage of patients with responses extreme ovaries, and cycle cancellations. These studies have been carried out with the premise that an optimal ovarian response results in obtaining 8-14 oocytes per puncture. Although it has also been shown that larger numbers of oocytes do not increase clinical variables such as implantation rates or live newborn per cycle, it is possible that these numbers of oocytes are insufficient in specific circumstances, for example, patients with a desire to have more pregnancy, patients undergoing IVF cycles with PGT-A, or gamete donors. For these reasons, and thanks to the improvements in cryopreservation programs and the induction of oocyte maturation with GnRH agonists, it is necessary to design protocols for the individualization of doses of medication aimed at obtaining greater quantities of oocytes. The objective of this pilot study is the evaluation of higher doses of Rekovelle (follitropin delta) aimed at obtaining 17 oocytes in voluntary donors.
IVI Madrid is the lead sponsor of 35 studies on the registry; 3 are open to participants now.
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Patients who meet the following inclusion criteria will be candidates to participate in the trial.
Exclusion criteria:
Patients who meet the following criteria will not be able to participate in the clinical trial:
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administration of a higher dose of Rekovelle (follitropin delta) to increase the ovarian response to 17 oocytes (the optimal range being 15 to 25 oocytes) in an oocyte donor population without compromising safety and efficacy.
Drug: Follitropin Delta, Recombinant
15 µg of follitropin delta will be administered subcutaneously daily
Assest the dose of 15µg of follitropin delta aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).
To evaluate the number of oocytes of a fixed dose of 15µg of the drug Rekovelle (follitropin delta) during the entire stimulation of oocyte donors aimed at obtaining 17 oocytes (considering the optimal range of oocytes from 15 to 25).
Time frame: Number of oocytes obtained inmediatly after the ovarian puncture in visit 5
Measure the incidence of ovarian hyperstimulation syndrome using15µg of follitropin delta aimed at obtaining 17 oocytes
Evaluate with a GOLAN scale. Golan classification: Classify early or late ovarian hyperstimulation syndrome, according to clinic, ultrasound and laboratory tests Mild ovarian hyperstimulation: * Grade 1 Abdominal discomfort and bloating * Grade 2 Grade 1 + nausea, vomiting, or diarrhea. Ovaries enlarged 5-12 cm in ø Moderate Hyperstimulation: • Grade 3 Grade 2 + ultrasound signs of ascites Severe hyperstimulation: * Grade 4 Grade 3 + clinical ascites, respiratory distress, hydrothorax * Grade 5 Grade 4 and hemoconcentration, hypovolemia, impaired coagulation and renal function (oligo / anuria)
Time frame: Through the study completion, an average 1 month.
Number of mature oocytes
Evaluate the number of mature oocyte
Time frame: Number of madure oocytes obtained inmediatly after the puncture in visit 5
Duration of stimulation in days
Evaluate the duration of stimulation in days
Time frame: Number of days during the ovarian stimulation up to 20 days
Number of blasts
Early stage of embryonic development that appears 4-6 days after fertilization and before implantation in the endometrium
Time frame: 4-6 days after fertilization and before implantation in the endometrium during the treatment.
Blast quality
Blast quality according to the Gardner scale, classification of blastocysts, where in addition to the structure of the inner cell mass (ICM) and cells of the trophectoderm, it provides a degree of expansion
Time frame: 4-6 days after fertilization and before implantation in the endometrium during the treatment.
Degree of satisfaction with the infertility treatment
Degree of satisfaction with the infertility treatment according to the EFESO, Questionnaire designed to know the degree of satisfaction of women who undergo ovarian stimulation treatment to treat their infertility questionnaire
Time frame: At the end of the treatment, an average 1 month.
Plan to share: No
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Ran from Sep 2021 to primary completion in Jun 2022, 8 months.
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