ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03309436
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
ShangHai Ji Ai Genetics & IVF Institute

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.


Condition or disease Intervention/treatment Phase
Infertility, Female Clomiphene Citrate Drug: Clomiphene Citrate protocol Procedure: Procedure Phase 4

Detailed Description:

This study receives patients from 2017 August to 2018 June who undergo ART treatment at Shanghai Jiai Genetics & IVF Institute and taken either CC or GnRH antagonist protocol(control group) for ovulation induction.

The investigators will record every patients' age, BMI, serum E2, P, LH level, infertility factors and pregnancy outcomes, counted the implantation rate and clinical pregnancy rate, and then used SPSS Software x2 test for statistical analysis, the significance was set at p<0.05.The investigators will also make a correlation analysis about the serum hormone level and pregnancy outcomes.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer
Actual Study Start Date : August 7, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Use Clomiphene Citrate protocol
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
Take CC 100mg/d at the same time with Gn until hCG injection.
Other Name: CC

Active Comparator: Procedure
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
When a dominant follicle diameter over 14mm or serum E2 over 350pg/ml, use GnRH-ant 0.25mg/d, until hCG injection.
Other Name: GnRH antagonist protocol




Primary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 4 weeks after embryo transfer for the patient ]

    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.



Secondary Outcome Measures :
  1. Ongoing pregnancy [ Time Frame: 12 weeks after embryo transfer for the patient ]
    Ongoing pregnancy is defined as a viable intrauterine pregnancy after 12 weeks of embryo transfer. Ongoing pregnancy rate per treatment cycle will also be calculated on intend-to-treat(ITT) basis.

  2. Implantation of transferred embryo [ Time Frame: 2 weeks after embryo transfer for the patient ]
    Implantation rate per embryo transferred will also be calculated.


Other Outcome Measures:
  1. Regression analysis 1 [ Time Frame: 12 weeks after embryo transfer for the patient ]
    Regression analysis about the pregnancy outcomes and patients' serum E2,P4,LH levels on the day of hCG injection

  2. Regression analysis 2 [ Time Frame: 12 weeks after embryo transfer for the patient ]
    Regression analysis about the pregnancy outcomes and patients' serum E2,P4,LH levels on the day of embryo transfer



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women 18-40 years of age who are scheduled for IVF or ICSI in our IVF institute while meeting the following criteria:

  1. AMH ≥ 2;
  2. Infertility factors: tubal factor, severe oligospermia, etc;
  3. FET cycle;
  4. Cleavage stage embryo transfer (Day 3).

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309436


Contacts
Contact: YINING XU, MD 86-13564548586 10301010067@fudan.edu.cn

Locations
China
Shanghai Jiai Genetics & IVF Institute Recruiting
Shanghai, China, 200011
Contact: XIAOXI SUN, MD    86-21-63456043    steven3019@hotmail.com   
Sponsors and Collaborators
ShangHai Ji Ai Genetics & IVF Institute
Investigators
Study Chair: XIAOXI SUN, MD Shanghai Jiai Genetics & IVF Institute

Responsible Party: ShangHai Ji Ai Genetics & IVF Institute
ClinicalTrials.gov Identifier: NCT03309436     History of Changes
Other Study ID Numbers: JIAI E2017-11
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Infertility, Female
Infertility
Genital Diseases, Male
Genital Diseases, Female
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators