Phase 3 Completed N=749 Randomized Single-blind Treatment

MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer

Infertility

Source: ClinicalTrials.gov NCT00884221 ↗

Enrolled (actual)

749

Serious AEs

1.6%

Results posted

Apr 2012

Primary outcomePrimary: Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set — 29; 27 Percentage of participants — p=0.499

Summary

The main purpose of this clinical research trial was to compare the ongoing pregnancy rate between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant follicle-stimulating hormone (FSH)), in cycles where a gonadotrophin-releasing hormone (GnRH) antagonist was used for prevention of premature luteinizing hormone (LH) surge and where a single embryo was transferred at the blastocyst stage.

Outcome Measures

Outcome	Result	p-value
PRIMARY Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set	29; 27	0.499
PRIMARY Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set	30; 27	0.387
SECONDARY Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set	8797; 7022	<0.001 sig
SECONDARY Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set	15.7; 12.6	<0.001 sig
SECONDARY Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set	2.8; 2.5	<0.001 sig
SECONDARY Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set	2.8; 2.1	<0.001 sig
SECONDARY Endocrine Profile (Progesterone), Intention-to-treat (ITT) Analysis Set	3.1; 3.1	0.630
SECONDARY Endocrine Profile (Prolactin), Intention-to-treat (ITT) Analysis Set	1544; 1410	0.047 sig
SECONDARY Endocrine Profile (Sex Hormone Binding Globulin), Intention-to-treat (ITT) Analysis Set	111; 107	0.009 sig
SECONDARY Endocrine Profile (Testosterone), Intention-to-treat (ITT) Analysis Set	2.5; 2.1	<0.001 sig
SECONDARY Number of Follicles of >= 12mm, 12-14 mm, 15-16 mm and >= 17 mm in Each Participant, Intention-to-treat (ITT) Analysis Set	10.9; 11.8; 3.3; 3.8; 2.7; 2.7	0.025 sig
SECONDARY Number of Oocytes Retrieved in Each Participant, Intention-to-treat (ITT) Analysis Set	9.1; 10.7	<0.001 sig
SECONDARY Fertilization, Intention-to-treat (ITT) Analysis Set	75; 76	0.969
SECONDARY Blastocyst Quality, Intention-to-treat (ITT) Analysis Set	7; 7; 7; 5; 10; 10	0.406
SECONDARY Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set	28; 26	0.398
SECONDARY Cumulative Live Birth for a Single Stimulation Cycle With Single Blastocyst Transfer From Fresh and 1 Year Frozen Embryo Replacement Cycles, Intention-to-treat (ITT) Analysis Set	40; 38	0.686

Eligibility Criteria

Inclusion criteria

Informed Consent Documents signed prior to screening evaluations
In good physical and mental health
Pre-menopausal females 21-34 years of age
Body mass index (BMI)18-25 kg/m2
Eligible for intracytoplasmic sperm injection (ICSI)
Unexplained infertility or partner with mild male factor infertility
Infertility for at least 12 months before randomization
Regular menstrual cycles of 24-35 days, presumed to be ovulatory
Hysterosalpingography, hysteroscopy, or transvaginal ultrasound documenting a uterus consistent with expected normal function
Transvaginal ultrasound documenting expected normal function of the ovaries
Early follicular phase serum levels of FSH between 1 and 12 IU/L
Early follicular phase total antral follicle (diameter 2-10 mm) count ≥ 10 for both ovaries combined
Willing to accept transfer of one blastocyst in the fresh cycle
Willing to undergo frozen embryo replacement cycles with transfer of one blastocyst per cycle within the first year after randomisation

Exclusion criteria

Known polycystic ovarian syndrome or known endometriosis stage I-IV
Diagnosed as "poor responder" in a previous controlled ovarian stimulation (COS) cycle
Severe ovarian hyperstimulation syndrome (OHSS)in a previous COS cycle
History of recurrent miscarriage
Current or past (12 months prior to randomization) abuse of alcohol or drugs, and/or current (last month) intake of more than 14 units of alcohol per week
Current or past smoking habit of more than 10 cigarettes per day
Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial
Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue
Previous participation in the trial
Use of any non registered investigational drugs during 3 months before randomization

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00884221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.