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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03006406
Other study ID # ENDO-1
Secondary ID
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


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
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Completed NCT03162315 - The Value of Progesterone for the Timing of the Embryo Transfer in IVF/ICSI: a Prospective Randomised Trial N/A
Recruiting NCT02496754 - The Application of a New Ovarian Stimulation Protocol in IVF N/A
Recruiting NCT06165367 - Hyaluronan-enriched Medium and Euploid Blastocyst Transfers N/A
Terminated NCT00737984 - Improving the Pregnancy Rate With Endometrial Sampling Before Intrauterine Insemination N/A