A phase III, randomized, controlled, single-blind, multicentre, parallel arm trial to assess the efficacy and safety of Pergoveris® (follitropin alfa and lutropin alfa) and GONAL-f® (follitropin alfa) for multifollicular development as part of an assisted reproductive technology treatment cycle in poor ovarian responders, as defined by the European Society of Human Reproduction and Embryology criteria

Phase 3

Conditions: infertility
poor ovarian responders
10033283

Registration Number: NL-OMON40576

Lead Sponsor: Merck

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

The current trial will enroll poor ovarian responders as aligned with the 2011 Consensus meeting of the ESHRE.
1. Subject must be a poor responder
Additional inclusion criteria are:
2. Female subjects, 18 to < 41 years of age (according to date of birth at time
of informed consent) who are eligible for ovarian stimulation and ART
treatment, including ICSI
3. Absence of anatomical abnormalities of the reproductive tract that
would interfere with implantation or pregnancy
4. Absence of any medical condition in which pregnancy is
contraindicated
5. Body mass index 18 to 30 kg/m2, inclusive
6. Motile, ejaculatory sperm must be available (donated and/or
cryopreserved sperm is allowed). Intracytoplasmic sperm injection will
be allowed during this trial.
7. Minimum of 1 month without treatment with either clomiphene
citrate or gonadotrophins prior to screening

Exclusion Criteria

1. Primary ovarian failure
2. Preimplantation genetic screening or diagnosis
3. Two episodes of POR after maximal stimulation
4. History or presence of tumors of the hypothalamus or pituitary gland
5. History or presence of ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst > 25 mm on the day of randomization
6. Presence of endometriosis grade III - IV, confirmed or suspected
7. Presence of uni- or bilateral hydrosalpinx
8. Abnormal gynecological bleeding of undetermined origin
9. Contraindication to being pregnant and/or carrying a pregnancy to
term
10. History or presence of ovarian, uterine or mammary cancer
11. Use of testicular or epididymal sperm

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the trial will be the total number of retrieved oocytes<br /><br>per subject. This endpoint reflects the clinical response to the stimulation<br /><br>and the subsequent success of infertility treatment in terms of onset of<br /><br>pregnancy. Oocyte retrieval takes place at Visit 12.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints for the trial will be:<br /><br>• Ongoing pregnancy rate defined as the percentage of subjects with a<br /><br>transvaginal US confirmation of at least one viable fetus (positive fetal heart<br /><br>beat) performed at Visit 16.<br /><br>• Live birth rate defined as the percentage of subjects with at least 1 live<br /><br>born neonate (Visit 17).<br /><br>• Embryo implantation rate defined as the number of gestational sacs divided by<br /><br>the number of embryos transferred per subject. This is determined at Visit 15.<br /><br>• Clinical pregnancy rate defined as the percentage of subjects with a<br /><br>transvaginal US confirmation of a gestational sac, with or without fetal heart<br /><br>activity performed at Visit 15.<br /><br>• Biochemical pregnancy rate defined as a positive beta-human chorionic<br /><br>gonadotrophin (β-hCG) result from the serum pregnancy test performed at Visit<br /><br>14.</p><br>