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

Endometrium Clinical Trial

Official title:

The Effect of Tamoxifen on Endometrial Thickness and Pregnancy Outcome in Women With Thin Endometrium Undergoing Frozen Thawed Cycle.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03060304
• Other study ID #: newivf20170217
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 18, 2017
• Last updated: February 22, 2017
• Start date: March 2017
• Est. completion date: June 2020

Study information

• Verified date: February 2017
• Source: Sun Yat-sen University
• Contact: Xing Yang, M.D. & Ph.D.
• Phone: 020-38048013
• Email: yxing_8358[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrium

Intervention

Drug:
• Tamoxifen
Patients in study group will receive tamoxifen at a daily dose of 40 mg from day 3 to day 8.
• estradiol valerate
Patients in control group will receive estradiol valerate at a dose of 3 mg twice per day from day 3.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endometrium thickness	Endometrial thickness was defined as the maximal distance between the echogenic interfaces of the endometrium and the myometrium in the plane of the central longitudinal axis of the uterus.	1-3 month
Primary	clinical pregnancy rate	Clinical pregnancy was considered with the presence of a gestational sac containing yolk sac at transvaginal ultrasonography, including ectopic pregnancy.clinical pregnancy rate is the number of clinical pregnancy patients /the total number of transferred patients in the group.	1-2years
Secondary	cycle duration	the total time of endometrium preparation	1-3 month
Secondary	cycle cancellation rate	cycle cancellation rate is the number of patients that cancell embryo transfer /the total number of patients in the group.	1-3 month
Secondary	implantation rate	Implantation rate was determined by the number of gestational sacs and the total number of embryos transferred at least 4 weeks after embryo transfer.	1-2 year
Secondary	miscarriage rate	miscarriage rate is the number of patients that find pregnancy loss /the total number of transferred patients in the group.	1-2 year
Secondary	live birth rate	live birth rate is the number of patients that delived /the total number of transferred patients in the group.	1-2 year