Follicular Long GnRH Agonist Versus Antagonist Protocol in PCOS Women Undergoing in Vitro Fertilization

NCT02496754 | Completed DMC

• 1 other identifier: RMCZZU-New protocol
• Study Type: interventional
• Target: 1,266
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical Pregnancy Rate; Ovulation Induction; IVF

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus

  5 weeks after embryo transfer

Secondary Outcomes (3)

• cumulative live birth rate

  2 years after oocyte retrivial

• Number of oocytes retrieved

  1 day at oocyte retrieved day

• 2 pronucleus (2PN) fertilization rate

  48 hours after oocyte retrieved day

Study Arms (2)

New protocol group

EXPERIMENTAL

Use long term GnRH-a 3.75mg at day 2 of menstrual cycle. Around 30 days later, controlled ovarian hyperstimulation using gonadotropins is initiated.

Drug: GnRH-a

GnRH-antagonist

ACTIVE COMPARATOR

In the GnRH antagonist protocol, Gn was injected from day 2-3 of the menstrual cycle and GnRH antagonist (Cetrotide; 0.25 mg) was added daily from day 6 of stimulation. When 2 dominant follicle ≥ 18 mm or three follicles ≥ 17 mm, recombinant human chorionic gonadotropin (hCG) was injected.

Drug: GnRH-anta

Interventions

GnRH-a DRUG

In experimental group, patients use long term GnRH-a; Patients' serum or follicle fluid will be collected if needed.

New protocol group

GnRH-anta DRUG

In control group, patients use GnRH-antagonist. Patients' serum or follicle fluid will be collected if needed.

GnRH-antagonist

Eligibility Criteria

• Age: 22 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• First IVF cycle;
• With normal ovarian reserve(FSH \< 10 mIU/mL; antral follicle count\>5);
• With normal uterine.
• PCOS women according to Rotterdam criteria

You may not qualify if:

• Pre-implantation genetic diagnosis cycles;
• Oocyte donation or sperm donation cycles.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Related Publications (2)

• 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: 16437491 BACKGROUND

• 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.

  PMID: 24006906 BACKGROUND

MeSH Terms

Interventions

ricin A-GnRH conjugate

Study Officials

• Yingpu Sun, M.D

  Zhengzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Reproductive Medical Center, 1st Affilated Hospital, Zhengzhou University

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 14, 2015
• Study Start: June 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

CN (1)