DRUG
GnRH-a
In experimental group, patients use long term GnRH-a; Patients' serum or follicle fluid will be collected if needed.
Follicular Long GnRH Agonist Versus Antagonist Protocol in PCOS Women Undergoing in Vitro Fertilization
Status
Completed
Phase
Not applicable
Enrollment
1,266
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
Pituitary down regulation is widely used during in vitro fertilization (IVF) procedures. It can suppress the spontaneous luteinizing hormone (LH) surge, and can also make follicles growth evenly. At present, standard gonadotropin releasing hormone analogue (GnRH-a) long protocol is used in arou Long term GnRH-a, which is usually used in patients with endometriosis,has been shown to increase IVF outcome by altering endometrial receptivity. Moreover, it is also very convenient because patients do not have to inject GnRH-a daily. In order to make patients feel more comfortable during IVF treatment, the investigators have used a new ovarian stimulation protocol since the beginning of 2015. The investigators give patients long term GnRH-a (3.75mg) once at menstrual cycle D2, and begin the use of Gn to stimulate follicle growth around 30 days later based on the hormone levels and follicle size. In the pilot observational study of several patients, no LH surge occurred during ovarian stimulation. The aim of this randomized controlled study is to compare the efficiency of this new protocol and standard GnRH-a long protocol in the investigator's center.
Full detailed description
The primary outcome is clinical prengancy rate. Secondary outcome is cumulative live birth rate. Other parameters include number of oocytes retrieved, 2 pronucleus (2PN) fertilization rate, high quality embryo formation rate, implantation rate, spontaneous abortion rate, and ectopic pregnancy rate.
Interventions
Treatment arms and agents.
DRUG
GnRH-anta
In control group, patients use GnRH-antagonist. Patients' serum or follicle fluid will be collected if needed.
Timeline
From registration to results.
First posted
Jul 14, 2015
Study start
Jun 2016
Primary completion
Dec 2022
Study completion
Dec 2024
Results posted
Not reported
Registry updated
Mar 5, 2025
Outcomes
What the study measures.
Primary outcomes
clinical pregnancy rate
Time frame · 5 weeks after embryo transfer
5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus
Secondary outcomes
cumulative live birth rate
Time frame · 2 years after oocyte retrivial
Number of oocytes retrieved
Time frame · 1 day at oocyte retrieved day
2 pronucleus (2PN) fertilization rate
Time frame · 48 hours after oocyte retrieved day
Number of 2PN/Matured oocytes
Eligibility
Who can take part.
- Minimum age
- 22 Years
- Maximum age
- 38 Years
- Sex
- FEMALE
- Healthy volunteers
- No
Inclusion Criteria: * First IVF cycle; * With normal ovarian reserve(FSH \< 10 mIU/mL; antral follicle count\>5); * With normal uterine. * PCOS women according to Rotterdam criteria Exclusion Criteria: * Pre-implantation genetic diagnosis cycles; * Oocyte donation or sperm donation cycles.
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Publications
Results and literature.
PMID 16437491 ↗Sallam HN, Garcia-Velasco JA, Dias S, Arici A. Long-term pituitary down-regulation before in vitro fertilization (IVF) for women with endometriosis. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004635. doi: 10.1002/14651858.CD004635.pub2.PMID 24006906 ↗Niu Z, Chen Q, Sun Y, Feng Y. Long-term pituitary downregulation before frozen embryo transfer could improve pregnancy outcomes in women with adenomyosis. Gynecol Endocrinol. 2013 Dec;29(12):1026-30. doi: 10.3109/09513590.2013.824960. Epub 2013 Sep 5.
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