NL-OMON40576
Not yet recruiting
Phase 3
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 - ESPART (Evaluating the Efficacy and Safety of Pergoveris® in ART)
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- infertility
- Sponsor
- Merck
- Enrollment
- 40
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
- •10\. History or presence of ovarian, uterine or mammary cancer
Outcomes
Primary Outcomes
Not specified
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