Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02496754
Other study ID # RMCZZU-New protocol
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT01008319 - Traditional Clomiphene Citrate Administration vs. Stair-step Approach Phase 3
Terminated NCT01075815 - A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age Phase 2
Terminated NCT01079949 - A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age Phase 2
Completed NCT01081639 - To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen Phase 3
Terminated NCT00697255 - A Phase 2 Trial to Evaluate if Corifollitropin Alfa (Org 36286), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (P05693) Phase 2
Completed NCT01183143 - Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization Phase 3
Completed NCT01081626 - Recombinant Follicle Stimulating Hormone (FSH) (Gonal-f®): Use in Ovulation Induction Phase 4
Completed NCT01111084 - A Prospective, Multi-centric Observational Study to Determine the Mono-bifollicular Development in Infertile Women Subjected to Ovulation Induction With Follitropin α N/A
Completed NCT04834791 - Letrozole Versus Gonadotropins in Clomiphene Citrate Resistance Phase 4
Completed NCT01645241 - Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation N/A
Terminated NCT04306692 - Myo-inositol Versus Clomiphene Citrate in PCOS Phase 4
Recruiting NCT03396380 - Effect of Vitamin D Supplement in Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome Phase 3
Terminated NCT00823472 - Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF) Phase 4
Completed NCT01110707 - A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve Phase 2
Completed NCT04610957 - Effect of Adding Isoflavonoids to Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome N/A
Completed NCT01185782 - SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women Phase 3
Terminated NCT00553514 - AS900672-Enriched in Ovulation Induction Phase 2
Completed NCT01152866 - An Open Label, Canadian Phase IIIb Study With Ovidrel in Ovulation Induction (OI) and Assisted Reproductive Technique (ART) N/A
Not yet recruiting NCT03307720 - Agonist Versus Classical HCG Trigger (Poor Responders, Normoresponders and High Responders) N/A
Completed NCT03825445 - GnRH Agonist Versus hCG Trigger in Ovulation Induction With Intrauterine Insemination. N/A