CLINICAL TRIALS PROFILE FOR MENOTROPINS
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All Clinical Trials for Menotropins
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01312766 ↗ | Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients | Completed | IBSA Institut Biochimique SA | Phase 3 | 2011-02-01 | The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF. |
| NCT01569945 ↗ | Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur | Completed | University Hospital, Gasthuisberg | N/A | 2004-09-01 | What is the best medication for hormonal stimulation in cycles with high intra-uterine insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days) or daily injections with Human Menopausal Gonadotropin (Menopur)? |
| NCT02069808 ↗ | Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct for Egg Bank Donation | Completed | Michigan Reproductive Medicine | Phase 4 | 2014-04-01 | Disprove the null hypothesis as follows: Among the investigator's egg bank donors undergoing ovulation induction with recombinant FSH medication per treatment protocol outlined below, use of adjunctive LH activity medication Menopur ™ , will result in the same number of mature oocytes recovered and cryopreserved as from egg donors not treated with Menopur™. Objectives: Compare efficacy of recombinant FSH (Follistim ™) with and without adjunct LH activity medication Menopur ™ for our volunteer egg bank donors. Efficacy defined as: 1. #Days of ovarian stimulation to GnRH agonist trigger. 2. Peak serum estradiol level on day of GnRH agonist trigger. 3. Number of follicles >15 mm average diameter on day of GnRH agonist trigger. 4. Number of mature oocytes recovered and cryopreserved. Study type: Randomized prospective clinical trial. Patient selection: Voluntary egg donors who have satisfied all screening criteria for FDA and the Michigan Egg Bank: Age range 18-to 39 years. BMI 18 to 25. Resting antral follicle count of 16 or greater. Cycle day 3 FSH <10 mIU/ml. AMH >2.0 ng/ml. Study design: Two groups- Group A- Recombinant FSH Follistim only; Group B- Recombinant FSH Follistim and adjunct Menopur. Both groups will use GnRH agonist trigger 36 hours prior to egg retrieval. Random number generator with patients assigned basd on odd or even numbers. Number of subjects: 25 in each group. Total of 50 subjects. This takes into account possible cycle cancellation for poor ovarian response or patient elective withdrawal to result in at least 20 subjects in each group completing the study. Primary measure of outcome: number of mature oocytes recovered and cryopreserved. Secondary measures of outcome: 1. #Days of ovarian stimulation to GnRH agonist trigger. 2. Peak serum estradiol level on day of GnRH agonist trigger. 3. Number of follicles >15 mm average diameter on day of GnRH agonist trigger. |
| NCT02418533 ↗ | Mono-menotropins Versus rFSH Protocol on Embryo Quality | Completed | Main Line Fertility Center | N/A | 2015-03-01 | This study is for couples pursuing in vitro fertilization (IVF) with preimplantation genetic screening (PGS) of embryos to achieve pregnancy. The objective of this clinical trial is to study the effect of mono-menotropins for COS versus recombinant follicle stimulating hormone (rFSH) on cleavage-stage and blastocyst embryo quality after IVF. Embryo quality parameters include conventional embryo grade, early embryo viability assessment (Eeva) time-lapse parameters, and chromosomal aneuploidy rates after PGS. This pilot study is expected to significantly contribute to optimization of treatment regimens and stimulation protocols to optimize embryo quality. |
| NCT02554279 ↗ | MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population | Completed | Ferring Pharmaceuticals | Phase 4 | 2015-08-31 | The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation (COS) following GnRH treatment. |
| NCT02992808 ↗ | Androgenic Profile Following Controlled Ovarian Stimulation | Unknown status | Sheba Medical Center | Phase 4 | 2016-12-01 | In this study the investigators will try to discover whether there is a difference for any of the stimulation preparations - recombinant FSH + recombinant LH (pergoveris & luveris) vs. human menopausal gonadotropin (menopur) during GnRH-antagonist cycles in the meaning of androgenic hormones profile. The study question is whether using recombinant LH will result in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using highly purified urinary gonadotropins with hCG mimicking LH activity. |
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