The Effect of Tamoxifen on Clinical Outcome in Women With Thin Endometrium Undergoing Frozen Thawed Cycle.

NCT ID: NCT03060304

Last Updated: 2017-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2020-06-30

Brief Summary

Cryopreservation of embryos created during fresh IVF cycles provides a less expensive and time-intensive opportunity for pregnancy. Ideal endometrium thickness is the key point to optimization FET cycle. Researches show that when endometrial thickness is less than 7mm, pregnancy rate dropped significantly. Tamoxifen has been reported to be oestrogenic on the lower genital tract. Several study on intrauterine insemination or ovulation induction suggest that tamoxifen may be a promising alternative for patients with thin endometrium. Based on this ,we want to evaluate the effects of tamoxifen on endometrial thickness and pregnancy outcome in women who failed to develop an adequate endometrial thickness in previous frozen embryo transfer cycle twice or even more times and willing to have another attempt.

Detailed Description

Objective: To investigate the effects of tamoxifen on endometrial thickness and pregnancy outcome in women with thin endometrium undergoing frozen thawed cycle.

Study design: This is a single center, randomize control clinical trial. We plan to recruit 100 patients from Mar 2017 to Dec 2019, who failed to develop an adequate endometrial thickness in previous frozen embryo transfer cycle twice or even more times and willing to have another attempt, dividing into two group, one prepare the endometrium through ovulation induction with tamoxifen and progesterone(Study Group), the other is hormone replacement cycle (control group).

Intervention: Study Group will give endometrial preparation with tamoxifen and progesterone, control group will prepared with estrogen and progesterone supplementation.

Main outcome measures: The primary outcome of the study was endometrium thickness and clinical pregnancy rate, the secondary outcomes are cycle duration, cycle cancellation rate, implantation rate, miscarriage rate, live birth rate.

Conditions

Endometrium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

Patients in study group will receive tamoxifen at a daily dose of 40 mg from day 3 to day 8. Follicle diameters are monitored by transvaginal ultrasound and serum levels of E2, P are tested on day 9. If there is a dominant follicle (almost 12 × 12 mm in diameter), endometrial thickness and endometrial pattern, as well as follicular diameters, were monitored daily or every other day till embryo transfer. Serum levels of E2, P are tested on the day before ovulation. If there isn't dominant follicle and intramuscular human menopausal gonadotropin at a dose of 75-150 IU was administered each day after day 12 if there follicle development was poor. The embryo transfer day is decided according embryo development.

Group Type: EXPERIMENTAL

Tamoxifen

Intervention Type: DRUG

Patients in study group will receive tamoxifen at a daily dose of 40 mg from day 3 to day 8.

control group

Patients in control group will receive estradiol valerate at a dose of 3 mg twice per day from day 3. Follicle diameters are monitored by transvaginal ultrasound and serum levels of E2, P are tested on day 9. If endometrial thickness \<7mm and E2\<100pg/ml, the dose of estradiol valerate can increase or combine other estradiol. Endometrial thickness and endometrial pattern, as well as follicular diameters, were monitored daily or every other day till embryo transfer. Serum levels of E2, P are tested on the day before endometrium transformation. The embryo transfer day is decided according embryo development. Serum levels of E2, P are tested on the day before embryo transfer.

Group Type: ACTIVE_COMPARATOR

estradiol valerate

Intervention Type: DRUG

Patients in control group will receive estradiol valerate at a dose of 3 mg twice per day from day 3.

Interventions

Tamoxifen

Patients in study group will receive tamoxifen at a daily dose of 40 mg from day 3 to day 8.

Intervention Type: DRUG

estradiol valerate

Patients in control group will receive estradiol valerate at a dose of 3 mg twice per day from day 3.

Intervention Type: DRUG

Other Intervention Names

Tam

Eligibility Criteria

Inclusion Criteria

1. Women age ≥20 years and ≤40 years;

2. patients that have at least 1 high quality blastocysts;

3. patients who are observed endometrial thickness ≤ 7mm in the past natural cycles or hormone replacement cycles repeatedly (twice or even more);

4. patients intends to continue to attempt another frozen embryo transfer cycle.

Exclusion Criteria

1. patients diagnosed intrauterine adhesions, uterine scarring diverticulum via Hysteroscopy or ultrasonography and have history of uterine cavity operation for the above indication;

2. patients have congenital uterine anomalies such as Gemini, the mediastinum in the uterus and so on.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yanhong Deng

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xing Yang, M.D. & Ph.D.

Role: STUDY_DIRECTOR

The Sixth Affiliated Hospital, Sun Yat-sen University

Central Contacts

Xing Yang, M.D. & Ph.D.

Role: CONTACT

yxing_8358@126.com

020-38048013

Other Identifiers

newivf20170217

Identifier Type: -

Identifier Source: org_study_id