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

NCT03060304 | Unknown Phase 4 DMC

• 1 other identifier: newivf20170217
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometrium

Keywords

tamoxifen; thin endometrium; frozen embryo transfer; pregnancy rate

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• cycle duration

  1-3 month

• cycle cancellation rate

  1-3 month

• implantation rate

  1-2 year

• miscarriage rate

  1-2 year

• live birth rate

  1-2 year

Study Arms (2)

study group

EXPERIMENTAL

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.

Drug: Tamoxifen

control group

ACTIVE COMPARATOR

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.

Drug: estradiol valerate

Interventions

Tamoxifen DRUG

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

Also known as: Tam

study group

estradiol valerate DRUG

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

control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women age ≥20 years and ≤40 years;
• patients that have at least 1 high quality blastocysts;
• patients who are observed endometrial thickness ≤ 7mm in the past natural cycles or hormone replacement cycles repeatedly (twice or even more);
• patients intends to continue to attempt another frozen embryo transfer cycle.

You may not qualify if:

• patients diagnosed intrauterine adhesions, uterine scarring diverticulum via Hysteroscopy or ultrasonography and have history of uterine cavity operation for the above indication;
• patients have congenital uterine anomalies such as Gemini, the mediastinum in the uterus and so on.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Interventions

Tamoxifen; Estradiol

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Xing Yang, M.D. & Ph.D.

  The Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

020-38048013; yxing_8358@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: February 18, 2017
• First Posted: February 23, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: February 24, 2017

Record last verified: 2017-02