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

Huijuan Kong, Linli Hu, Ling Nie, Xiaona Yu, Wei Dai, Jing Li, Caihong Chen, Zhiqin Bu, Hao Shi, Qiongfang Wu, Yichun Guan, Yingpu Sun, Huijuan Kong, Linli Hu, Ling Nie, Xiaona Yu, Wei Dai, Jing Li, Caihong Chen, Zhiqin Bu, Hao Shi, Qiongfang Wu, Yichun Guan, Yingpu Sun

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 .

Conflict of interest statement

Ethics approval and consent to participate

This study has been approved by the ethics committee of the First Affiliated Hospital of Zhengzhou University, the Third Affiliated Hospital of Zhengzhou University, and Jiangxi Provincial Maternal and Child Health Hospital. It will abide by the relevant laws and regulations on drug testing ethics. All patients will sign the informed consent for the study protocol and reserve the right to withdraw at any time. The archives of the pregnant patients will be kept for over 50 years according to the requirement of clinical trials.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant flow chart through the trial
Fig. 2
Fig. 2
Normal GnRHa protocol
Fig. 3
Fig. 3
Shorten GnRHa protocol

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