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)

Merck0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•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

•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
•11. Use of testicular or epididymal sperm

发起方