Endometrial Preparation in Frozen Embryo Transfer Cycles

NCT03540979 | Unknown DMC

• 1 other identifier: MMC180016-18CTIL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison of protocols for frozen embryo transfer (ET): One protocol using Estrogen supplements and the second protocol using Letrozole

Conditions

Reproductive Behavior

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy

  The primary outcome measure is clinical pregnancy rate defines as intrauterine pregnancy with positive fetal heart beat measure 2-3 weeks after positive β-hCG TEST ( 6-7 weeks of pregnancy)

  4 to 5 weeks after the embryo transfer ( 6-7 weeks of pregnancy).

Secondary Outcomes (1)

• pregnancy rate

  12-14 days after the embryo transfer

Study Arms (2)

Estrogen

ACTIVE COMPARATOR

Endometrial preparation: Estrogen supplements (Estradiol 6mg/d) will be started at the 2nd-3rd day of the cycle. First US scan will be performed after 10 days. If necessary, adjusting the estradiol doses will be performed according to the physician decision. After achieving trilinear endometrial thickness ≥8mm progesterone supplements (Endometrin 100mg\*3/d) will be administrated. Embryo transfer will be performed after completing 5 days of progesterone supplements (at the 6th day after starting the progesterone supplements).

Procedure: endometrial preparation for frozen blastocyst transfer; Drug: Estrofem; Drug: Endometrin 100Mg Vaginal Insert

Letrozole

EXPERIMENTAL

Women in the Letrozole arm will be treated with Aromatase inhibitors ( Letrozole; 2.5 mg per day) starting at the 3rd day of the cycle for 5 days. US scan,and blood work for serum Estradiol (E2) and progesterone (P) will initially be examined 3-5 days after the last Letrozole pill. Following US scans and serum E2+P will be performed according to the treating physician decision. When US scan demonstrate trilaminar endometrium ≥8 mm and the dominant follicle will be ≥18mm, hCG will be administrated ( recommbinant hCG - Ovitrelle 250 mcg) and 3 days later vaginal Endometrin 100mg\*3/d will be started. Single vitrified-warmed blastocyst transfer will be performed after completing 4 days of the progesterone supplements (7 days from hCG administration).

Procedure: endometrial preparation for frozen blastocyst transfer; Drug: Letrozole; Drug: Ovidrel; Drug: Endometrin 100Mg Vaginal Insert

Interventions

endometrial preparation for frozen blastocyst transfer PROCEDURE

medical endometrial preparation for frozen blastocyte transfer

Estrogen; Letrozole

Letrozole DRUG

Aromatase inhibitor - 2.5mg/d for 5 days

Also known as: Femara

Letrozole

Ovidrel DRUG

recommbinant hCG 250 mcg- single sc injection to induce ovulation

Also known as: Ovidre

Letrozole

Estrofem DRUG

Estrofem 2mg\*3/d for endometrial preparation

Also known as: Estrsdiol

Estrogen

Endometrin 100Mg Vaginal Insert DRUG

vaginal tab for lutheal support

Estrogen; Letrozole

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient undergoing frozen embryo transfer cycle
• Single blastocyst transfer
• Normal uterine cavity.

You may not qualify if:

• Woman age older than 40
• Cleavage stage embryo
• More than 3 previous transfers w/o pregnancy
• Oocyte donation cycle.

Sponsors & Collaborators

• Meir Medical Center: lead

MeSH Terms

Conditions

Reproductive Behavior

Interventions

Letrozole; Ovidrel; estradiol, estriol drug combination; Progesterone

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: May 30, 2018
• Study Start: June 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 30, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share