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Reprod Health. 2018 Dec 20;15(1):213. doi: 10.1186/s12978-018-0639-8.

A multi-center, randomized controlled clinical trial of the application of a shortened protocol of long-acting Triptorelin down-regulated prior to IVF/ICSI among patients with endometriosis: A protocol.

Kong H1,2, Hu L1,2, Nie L3, Yu X4, Dai W1,2, Li J1,2, Chen C1,2, Bu Z1,2, Shi H1,2, Wu Q3, Guan Y4, Sun Y5,6.

Author information

1
Center for Reproductive Medicine, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
2
Henan Key Laboratory of Reproduction and Genetics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
3
Jiangxi Maternal and Child Health hospital, Nanchang, China.
4
Center for Reproductive Medicine, the Third Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
5
Center for Reproductive Medicine, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. syp2008@vip.sina.com.
6
Henan Key Laboratory of Reproduction and Genetics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. syp2008@vip.sina.com.

Abstract

BACKGROUND:

Endometriosis is the major cause of progressive pelvic pain and subfertility. Up to 50% of reproductive-age women suffer from pelvic pain. Endometriosis is a classic indication for IVF. Compared with women whose inability to procreate is caused by simple tubal infertility, women with endometriosis often have lower pregnancy rates following in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI). The administration of gonadotrophin-releasing hormone (GnRH) agonists prior to IVF/ICSI can improve the successful pregnancy rate. Whether a briefer treatment interval would be efficacious has not been studied.

METHODS/DESIGN:

Eligible and consenting women will be randomly assigned to one of two treatments (one cycle of a GnRH agonist or two cycles of a GnRH agonist) prior to IVF/ICSI using a table of random numbers. The primary outcome of this trial is clinical pregnancy rate. Other outcomes include gonadotrophin (Gn) duration, the total dose of follicle-stimulating hormone (FSH) used, number of oocytes retrieved, number of embryos available for transfer, implantation rate, the abortion rate, live birth rate, and incidence of moderate-to-severe ovarian hyperstimulation. The sample size of this trial is estimated to be 421 participants for each of the two arms. Appropriate interim analyses will be conducted by a data monitoring and ethics committee (DMEC), and the final test will be an intention-to-treat analysis.

TRIAL REGISTRATION:

This trial has been assigned the following registry number: NCT03006406 .

PMID:
30572916
PMCID:
PMC6302481
DOI:
10.1186/s12978-018-0639-8
[Indexed for MEDLINE]
Free PMC Article

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