Luteal Phase Support During Frozen Embryo Transfer Cycle

NCT04013438 | Completed Phase 3

• 1 other identifier: Royan, Female Infertility,LPS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

We aimed to decrease quantity of exogenous estrogen and evaluated the success rate of ongoing pregnancy in women undergone artificial FET who have a surplus embryos at previous fertility treatment cycles. In this study, endometrial prepared with standard long GnRH protocol and for luteal phase support patients received 6 mg oral E2 and intramuscularly P 100 mg/d and embryos on day 2-3 were transferred. Control group continued E2 until 12 week of pregnancy, while for cases after identify gestational sac with heart beat (the 6 week of pregnancy) by vaginal ultrasonography, E2 will discontinued.

Conditions

Infertility, Female; Frozen Embryo Transfer

Keywords

Ongoing pregnancy rate; Estrogen; Frozen embryo transfer; Luteal phase support

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate after frozen embryo transfer

  Ongoing pregnancy was defined when the pregnancy had completed ≥20 weeks of gestation.

  ≥20 weeks of gestational age

Secondary Outcomes (2)

• Maternal serum estrogen level

  The start day of using progesterone for luteal support in FET cycle (day 15 after onset estradiol), the day of embryo transfer (approximately 17-18 days after onset estradiol), 6 and 12 weeks of gestational age

• Maternal serum progesterone level

  The start day of using progesterone for luteal support in FET cycle (day 15 after onset estradiol), the day of embryo transfer (approximately 17-18 days after onset estradiol), 6 and 12 weeks of gestational age

Study Arms (2)

FET cycle, discontinue estradiol after 6 gestational weeks

EXPERIMENTAL

In patients 35 days after embryo transfer and observation of gestational sac with heart beat (6 weeks of pregnancy) by ultrasound, exogenous estrogen will discontinued while progesterone will remain daily use until twelfth week of pregnancy.

Drug: Strogen

FET cycle, continue estradiol till 12 gestational weeks

ACTIVE COMPARATOR

Control group receive 6 mg oral estrogen and 100 mg intramuscularly progesterone until 12 week of pregnancy.

Drug: Strogen

Interventions

Strogen DRUG

The OCP-LD begins in 2 to 3 days of the last menstrual cycle and then 500 μgr/d GnRH-a will received on day 17 for fourteen days. Then in 2-3 days of the next menstrual cycle, GnRH-a reduced to 200 μgr/d dose. the patients will receive 6 mg oral that will be continued for 14 days and during this time endometrium thickness evaluated by vaginal ultrasonography. If endometrial thickness is estimated ≥7mm, intramuscularly progesterone 100 mg/d will be started. After the onset of progesterone (days 17 to 18 cycles) frozen embryos transferred. Control group receive 6 mg oral estrogen and 100 mg intramuscularly progesterone until 12 week of pregnancy. The levels of maternal estrogen and progesterone was measured at the time of the starting day of progesterone (day 15), the day of embryo transfer, 6 and 12 weeks of pregnancy.

Also known as: estradiol till 12 gestational weeks

FET cycle, continue estradiol till 12 gestational weeks

Eligibility Criteria

• Age: 21 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with surplus embryos undergone infertility treatment cycles (e.g. OHSS, inadequate endometrium, surplus frozen embryo from any cause)
• Age 21-37 years
• Normal BMI (18.5 \<BMI \<30)
• IVF / ICSI or IVF or ICSI cycles with antagonists or agonists protocols
• Frozen embryos on 2-3 days

You may not qualify if:

• Endometrial thickness ≤7mm
• Egg Donors
• Surrogacy
• Male factor infertility with azoospermia
• Age \<37 years old
• Hydrosalpinx
• Uterine anomalies
• Myoma with a compression effect or submocusa myoma
• PGD
• Blastocyst embryo transfer, ZIFT and GIFT

Sponsors & Collaborators

• Royan Institute: lead

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Publications (1)

• Ghaffari F, Chekini Z, Vesali S. Duration of estradiol supplementation in luteal phase support for frozen embryo transfer in hormone replacement treatment cycles: a randomized, controlled phase III trial. Arch Gynecol Obstet. 2022 Mar;305(3):767-775. doi: 10.1007/s00404-021-06173-w. Epub 2021 Sep 24.

  PMID: 34561715 DERIVED

MeSH Terms

Conditions

Infertility, Female

Interventions

IDS 89 Sabal serrulata extract

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: July 9, 2019
• Study Start: November 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: April 30, 2019
• Last Updated: July 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)