The Application of a New Ovarian Stimulation Protocol in IVF

Ovulation Induction Clinical Trial

Official title:

The Application of a New Ovarian Stimulation Protocol in IVF: a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02496754
• Other study ID #: RMCZZU-New protocol
• Status: Recruiting
• Phase: N/A
• Start date: June 2015
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Caihong Chen, M.D
• Phone: 86-371-67967161
• Email: reinbow[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 around 85% patients in the investigator's center. However, patients have to inject short term GnRH-a 0.05mg or 0.1mg daily for around 3 weeks in one IVF cycle.

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.

Description:

The primary outcome is ongoing pregnancy 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 38 Years

Eligibility

Inclusion Criteria:

• First IVF cycle;

• With normal ovarian reserve(FSH < 10 mIU/mL; antral follicle count>5);

• With normal uterine.

Exclusion Criteria:

• Pre-implantation genetic diagnosis cycles;

• Oocyte donation or sperm donation cycles.

Related Conditions & MeSH terms

• Clinical Pregnancy Rate
• Ovulation Induction

Intervention

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

Locations

Country	Name	City	State
China	Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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;(1):CD004635. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	12 weeks after embryo transfer, gestational sac with fetal heart present inside uterus	12 weeks after embryo transfer
Secondary	Number of oocytes retrieved		1 day at oocyte retrieved day
Secondary	2 pronucleus (2PN) fertilization rate	Number of 2PN/Matured oocytes	48 hours after oocyte retrieved day