Effect of Shorten Gonadotropin-releasing Hormone Agonist Therapy on the Outcome of in Vitro Fertilization-Embryo Transfer in Patients With Endometriosis

Clinical Pregnancy Rate Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03006406
• Other study ID #: ENDO-1
• Status: Recruiting
• Phase: N/A
• First received: December 28, 2016
• Last updated: December 29, 2016
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: December 2016
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Huijuan Kong, M.D.
• Phone: 86-371-67966161
• Email: luckyjuanjuan819[@]126.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which can down-regulate pituitary function causing a temporary low estrogen state. Since endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control the growth of endometriosis by inhibiting ovary function.Some scholars have found that, for adenomyosis patients who received a super long protocol (pretreatment of long-acting GnRH-a for 1-2 months) in IVF treatment, the pregnancy outcome is comparable to that of the controls with normal uterus. Thus, the aim of this study is to compare the clinical pregnancy rate in patients treated with GnRH-a for 1, or 2 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 42 Years

Eligibility

Inclusion Criteria:

• first IVF cycle;

• with normal ovarian reserve(FSH(10miu/ml; antral follicle count )3)

• with normal uterine

Exclusion Criteria:

• Pre-implantation genetic diagnosis cycles;

• Oocyte donation cycles

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clinical Pregnancy Rate
• Endometriosis

Intervention

Drug:
• Long term GnRH-a (3.75mg)
patient in this group only receive GnRH-a 3.75 for pituitary down-regulation

Locations

Country	Name	City	State
China	Reproductive Medical Center, First 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)

Mijatovic V, Florijn E, Halim N, Schats R, Hompes P. Adenomyosis has no adverse effects on IVF/ICSI outcomes in women with endometriosis treated with long-term pituitary down-regulation before IVF/ICSI. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):62-5. doi: 10.1016/j.ejogrb.2010.02.047. — View Citation

van der Houwen LE, Mijatovic V, Leemhuis E, Schats R, Heymans MW, Lambalk CB, Hompes PG. Efficacy and safety of IVF/ICSI in patients with severe endometriosis after long-term pituitary down-regulation. Reprod Biomed Online. 2014 Jan;28(1):39-46. doi: 10.1016/j.rbmo.2013.09.027. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate		5 weeks after embryo transfer	Yes
Secondary	Number of oocytes retrieved		1 day at oocyte retrieved day	No
Secondary	2 pronucleus(2PN)fertilization rate	Number of 2PN/Matured oocytes	48hours after oocyte retrieved day	No