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Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer

Primary Purpose

Infertility, Female, Clomiphene Citrate

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Clomiphene Citrate protocol
Procedure
Sponsored by
ShangHai Ji Ai Genetics & IVF Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Jiai Genetics & IVF InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Use Clomiphene Citrate protocol

Procedure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Ongoing pregnancy
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.
Implantation of transferred embryo
Implantation rate per embryo transferred will also be calculated.

Full Information

First Posted
February 28, 2017
Last Updated
October 7, 2017
Sponsor
ShangHai Ji Ai Genetics & IVF Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03309436
Brief Title
Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer
Official Title
Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ShangHai Ji Ai Genetics & IVF Institute

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female, Clomiphene Citrate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Use Clomiphene Citrate protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Procedure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate protocol
Other Intervention Name(s)
CC
Intervention Description
Take CC 100mg/d at the same time with Gn until hCG injection.
Intervention Type
Procedure
Intervention Name(s)
Procedure
Other Intervention Name(s)
GnRH antagonist protocol
Intervention Description
When a dominant follicle diameter over 14mm or serum E2 over 350pg/ml, use GnRH-ant 0.25mg/d, until hCG injection.
Primary Outcome Measure Information:
Title
Clinical pregnancy
Description
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.
Time Frame
4 weeks after embryo transfer for the patient
Secondary Outcome Measure Information:
Title
Ongoing pregnancy
Description
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.
Time Frame
12 weeks after embryo transfer for the patient
Title
Implantation of transferred embryo
Description
Implantation rate per embryo transferred will also be calculated.
Time Frame
2 weeks after embryo transfer for the patient
Other Pre-specified Outcome Measures:
Title
Regression analysis 1
Description
Regression analysis about the pregnancy outcomes and patients' serum E2,P4,LH levels on the day of hCG injection
Time Frame
12 weeks after embryo transfer for the patient
Title
Regression analysis 2
Description
Regression analysis about the pregnancy outcomes and patients' serum E2,P4,LH levels on the day of embryo transfer
Time Frame
12 weeks after embryo transfer for the patient

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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: AMH ≥ 2; Infertility factors: tubal factor, severe oligospermia, etc; FET cycle; Cleavage stage embryo transfer (Day 3). Exclusion Criteria: BMI ≤ 18.4 or ≥ 25.0; Have pregnancy complications; Genital tract malformations, uterine cavity diseases, PCOS; Endometriosis; Genetic diseases, severe somatic diseases, mental disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YINING XU, MD
Phone
86-13564548586
Email
10301010067@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
XIAOXI SUN, MD
Organizational Affiliation
Shanghai Jiai Genetics & IVF Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Jiai Genetics & IVF Institute
City
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XIAOXI SUN, MD
Phone
86-21-63456043
Email
steven3019@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Effects of Clomiphene Citrate Ovulation Induction on Frozen Embryo Transfer

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