Clinical trial NCT02496754: Follicular Long GnRH Agonist Versus Antagonist Protocol in PCOS Women Undergoing in Vitro Fertilization
Official title: Follicular Long GnRH Agonist Versus Antagonist Protocol in PCOS Women Undergoing in Vitro Fertilization: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Pregnancy Rate
Ovulation Induction
IVF
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 1266
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 5 weeks after embryo transfer
Secondary outcomes:
measure: cumulative live birth rate
timeFrame: 2 years after oocyte retrivial
measure: Number of oocytes retrieved
timeFrame: 1 day at oocyte retrieved day
measure: 2 pronucleus (2PN) fertilization rate
timeFrame: 48 hours after oocyte retrieved day
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: Zhengzhou University
name: Yingpu Sun, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.