Luteal Support in Frozen-Thawed Embryo Transfer Cycles

December 25, 2021 updated by: Emre Göksan Pabuçcu, Centrum Clinic IVF Center

Which Luteal Support in Frozen-Thawed Embryo Transfer Cycles: A Randomized Controlled Trial

This study evaluates the clinical efficacy of 3 different luteal phase support in patients undergoing frozen-thawed embryo transfer cycles. Endometrium preparation will be hormone replacement in all cycles. Starting from day 11, group 1 will receive 100 mg micronized progesterone parenteral daily injections, group 2 will receive 90 mg bioadhesive gel vaginal twice daily and group 3 will receive 40 mg oral dydrogesterone daily tablets.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In natural pregnancy, successful implantation and pregnancy necessitates well-functioning corpus luteum. Luteal phase support (LPS) is critical in assisted conception cycles particularly for replacement frozen embryo transfer cycles owing to lack of corpus luteum. 3 different LPS options have been suggested:

  • Progesterone in oil (intramuscular injections) is rapidly absorbed after i.m. injection and high progesterone plasma concentrations are reached after approximately 2h. Despite satisfactory plasma levels, the possible side-effects of pain and swelling are limiting the use.
  • Vaginal application of progesterone is widely accepted with satisfactory endometrial levels and patient convenience. However, increased vaginal discharge and possible vaginal irritation are the most common side effects.
  • Oral administration of synthetic progesterone (dydrogesterone) would offer a convenient way of progesterone administration. Better bioavailability than natural progesterone and less cost makes dydrogesterone preferable. Also, good quality evidence revealed satisfactory outcomes in fresh embryo transfer cycles. However, there is lack of good quality evidence for dydrogesterone as a LPS in frozen-thawed cycles.

The investigator's aim is to compare 3 widely used LPS in frozen-thawed embryo transfer cycles.

Following allocation of the subjects, hormone replacement will be scheduled for the endometrial preparation. Briefly; On day 2 of menstrual bleeding, endometrial preparation with oral estradiol (E2) (2 mg twice daily) will be initiated. Approximately 10 days after initiation of E2 administration, the subject will undergo a transvaginal ultrasound examination to assess endometrial development and serum progesterone (P) level will be checked. Once the subject achieved a trilaminar endometrium with a thickness of >7 mm with serum P levels <1.5 ng/ml, she will start the progesterone treatment to which she will be randomized to one of the 3 arms. After 3 days of P treatment along with E2 pills, cleavage embryo transfer will be performed. If the subject will receive blastocyst, 5 days of P treatment will be scheduled.

If these criteria were not met at the first evaluation, she will allowed up to 10 additional days (20 days total) of estrogen stimulation.

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ufuk University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • woman aged 20-40 years
  • Having available blastocyst(s) cryopreserved by vitrification method.

Exclusion Criteria:

  • requirement for fresh embryo(s);
  • presence of any clinically relevant systemic disease contraindicated for assisted reproduction or pregnancy
  • history of more than three failed cycles of IVF
  • history of recurrent abortions
  • allergy history for relevant drugs
  • body mass index of <18 or >38 kg/m2 at screening
  • current breastfeeding or pregnancy
  • refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests
  • trophectoderm or blastomere biopsy of the blastocyst(s) to be transferred

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intramuscular progesterone
progestan (progesterone) 50 mg/ml ampoules, 2 ampoules (100 mg) intramuscular starting from day 11 of the endometrial preparation cycle.
Drug: Progesterone 50Mg/mL Oil
100 mg daily intramuscular injections
Active Comparator: vaginal progesterone
crinone %8 bioadhesive gel (progesterone) 90 mg, twice daily (180 mg/day) starting from day 11 of the endometrial preparation cycle.
Drug: Crinone 8% Vaginal Gel
180 mg daily vaginal gels
Experimental: oral dydrogesterone
oral dydrogesterone (progesterone) 10 mg tablets, 2x2 (40 mg total)
Drug: Dydrogesterone 10Mg Tablet (duphaston)
40 mg daily oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ongoing pregnancy rate
Time Frame: 12th week of pregnancy
fetal cardiac activity beyond 12th week of gestation
12th week of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 6th week of pregnancy
fetal cardiac activity
6th week of pregnancy
abortion rate
Time Frame: during first 10 weeks of gestation
miscarriage of the pregnancy pregnancy recently confirmed with positive beta hCG blood test
during first 10 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centrum Clinic IVF Center

Investigators

  • Study Director: Emre Pabuccu, Assoc. Prof., Ufuk University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Actual)

December 18, 2021

Study Completion (Actual)

December 20, 2021

Study Registration Dates

First Submitted

May 9, 2019

First Submitted That Met QC Criteria

May 10, 2019

First Posted (Actual)

May 13, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 25, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • centrumtupbebek

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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