Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer

NCT03309436 | Unknown Phase 4

• 1 other identifier: JIAI E2017-11
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

Clomiphene citrate has been widely used for treatment of infertility for decades. Although its anti-estrogenic effects leads to low pregnancy rate, clomiphene citrate is still a first-line treatment for ovulation induction because of its simple usage, low prices, no injection and low risk of ovarian hyperstimulation syndrome. Clomiphene citrate shows high affinity with estrogen receptor, which inhibits endometrial proliferation, inevitably leads to a decline in endometrial receptivity, thus affecting the success rate of IVF. In that case, use clomiphene citrate for ovulation induction is lost more than gained based on fresh embryo transfer. But recently, some researchers have proposed to extend the time from ovulation induction to embryo transfer, and the increased level of estradiol can replace clomiphene citrate to combine with the receptor, so that the uterine environment is more conducive to pregnancy. Therefore, use clomiphene citrate based on vitrification of embryo maybe a good way for treatment of infertility. At present, using frozen embryo transplantation after ovulation induction by clomiphene citrate is a common treatment, but few research has mentioned the best time for embryo implantation. The investigators research is to find the most appropriate time for frozen embryo implantation after using clomiphene citrate for ovulation induction.

Conditions

Infertility, Female; Clomiphene Citrate

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy

  Clinical pregnancy is defined as the presence of a gestational sac confirmed by transvaginal ultrasound examination. Clinical pregnancy rate per treatment cycle will also be calculated based on ITT.

  4 weeks after embryo transfer for the patient

Secondary Outcomes (2)

• Ongoing pregnancy

  12 weeks after embryo transfer for the patient

• Implantation of transferred embryo

  2 weeks after embryo transfer for the patient

Other Outcomes (2)

• Regression analysis 1

  12 weeks after embryo transfer for the patient

• Regression analysis 2

  12 weeks after embryo transfer for the patient

Study Arms (2)

Use Clomiphene Citrate protocol

EXPERIMENTAL

Ovulation induction: regular Clomiphene Citrate protocol. Start use rFSH or HMG from day 2/3 of the menstrual cycle, the initial dosage is determined by patients' age, BMI, antral follicle number, FSH, E2, AMH and past ovarian response, usually 150-225IU/d, until hCG injection. At the same time, take CC 100mg/d until hCG injection. The dosage of Gn will be adjust by serum E2, P, LH and the development of follicular.

Drug: Clomiphene Citrate protocol

Procedure

ACTIVE COMPARATOR

Ovulation induction: regular GnRH antagonist protocol. Start use rFSH or HMG from day 2/3 of the menstrual cycle, the initial dosage is determined by patients' age, BMI, antral follicle number, FSH, E2, AMH and past ovarian response, usually 150-225IU/d, until hCG injection. When a dominant follicle diameter over 14mm or serum E2 over 350pg/ml, use GnRH-ant 0.25mg/d, until hCG injection. The dosage of Gn will be adjust by serum E2, P, LH and the development of follicular.

Procedure: Procedure

Interventions

Clomiphene Citrate protocol DRUG

Take CC 100mg/d at the same time with Gn until hCG injection.

Also known as: CC

Use Clomiphene Citrate protocol

Procedure PROCEDURE

When a dominant follicle diameter over 14mm or serum E2 over 350pg/ml, use GnRH-ant 0.25mg/d, until hCG injection.

Also known as: GnRH antagonist protocol

Procedure

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18-40 years of age who are scheduled for IVF or ICSI in our IVF institute while meeting the following criteria:
• AMH ≥ 2;
• Infertility factors: tubal factor, severe oligospermia, etc;
• FET cycle;
• Cleavage stage embryo transfer (Day 3).

You may not qualify if:

• BMI ≤ 18.4 or ≥ 25.0;
• Have pregnancy complications;
• Genital tract malformations, uterine cavity diseases, PCOS;
• Endometriosis;
• Genetic diseases, severe somatic diseases, mental disorder.

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

Shanghai Jiai Genetics & IVF Institute

Shanghai, 200011, China

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Interventions

Methods

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• XIAOXI SUN, MD

  Shanghai Jiai Genetics & IVF Institute

  STUDY CHAIR

Central Study Contacts

YINING XU, MD

CONTACT

86-13564548586; 10301010067@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: October 13, 2017
• Study Start: August 7, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: October 13, 2017

Record last verified: 2017-08

Locations

CN (1)