Progesterone Supplementation on Women Having Low Progesterone Levels on Transfer Day

December 4, 2023 updated by: Le Thi Minh Chau, Tu Du Hospital

Effectiveness of Progesterone Supplementation for Women Having Low Progesterone Levels on the Day of Frozen Embryo Transfer

The main objective of this study is to compare clinical pregnancy rates between two groups of women who have progesterone levels below 10 ng/mL on the day of frozen embryo transfer: group 1 (vaginal micronized progesterone supplemented with progesterone intramuscular 50 mg per day) and group 2 (vaginal micronized progesterone with no supplementation)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Trial Design:

Single center, longitudinal, randomized, interventional, controlled, pharmacological study, enrolling women attending clinical Centers of medically assisted reproduction (ART).

The study protocol consists in the record of all the diagnostic and clinical outcome parameters, according to clinical practice, for the following patient cohorts:

  • The patients who are undergoing frozen embryo transfers with blastocyst or cleavage stage embryos and have progesterone levels below 10 ng/mL on the day of embryo transfer

  • Study groups

    • Group supplemented with progesterone intramuscular 50 mg per day until the day of beta-hcg testing (Intervention group);

    • Group with no supplementation (Control group).

      • Endometrial cycle is started with estradiol valerate dose of 4 mg to 8 mg per day, the patients then are appointed to have ultrasound scan of their endometrium every 3 to 7 days and the dose of estradiol may be increased to 16 mg per day maximum depends on the thickness of endometrium; when their endometrium reach 8 mm or higher and duration of endometrial preparation is ≥ 12 days, the embryo transfer will be planned and transvaginal progesterone are prescribed according to the day of transfer.
      • If this is the first cycle of embryo transfer and she is < 35 years of age, 1 grade 1 embryo is transferred, otherwise 2 embryos are transferred.
      • In the morning of embryo-transferred day, all patients will have their blood tested for progesterone levels, if their levels below 10 ng/mL, they will be recruited into the study and randomized into two groups.
      • In the study group, the patients will be prescribed with intramuscular progesterone supplemetation 50 mg + 800mg vaginal micronized progesterone per day for 14 days, until the day of beta-hcg testing.
      • In the control group, the patients will continue their regular medications (800mg vaginal micronized progesterone per day) until the day of beta-hcg testing without any progesterone supplementation.
      • If the beta-hcg test is positive, the patients will be continued their prescriptions depending on study or control group as mentioned above till 7 weeks of pregnancy when the fetal heart can be confirmed, then the patients will be followed up till 11 - 12 weeks of pregnancy

Study Type

Interventional

Enrollment (Estimated)

824

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 70000
        • Recruiting
        • Department of Infertility of Tu Du hospital
        • Sub-Investigator:
          • Anh Q Nguyen, MMSc
        • Sub-Investigator:
          • Thinh P Ong, MD
        • Principal Investigator:
          • Chau TM Le, PhD
        • Sub-Investigator:
          • Matheus Roque, PhD
        • Sub-Investigator:
          • Carlo Alviggi, Prof.
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Tu K Duong, MMSc

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients undergone ART with frozen embryo transfer, blastocyst or cleavaged stage embryo transfer, from 18-45 years of age
  • Normal BMI
  • HRT for Endometrial preparation in FET cycles

Exclusion Criteria:

  • Oocyte donor cycles
  • Surrogacy
  • IVM
  • PGT
  • Abnormal Uterine (firbroids 0 -> 3 according to FIGO classification, polyp, adenomyosis, congenital malformation)
  • Uterus fibroids type 4,5 (Figo classification) > 4cm
  • History of recurrent implantation failure
  • Endometrial thickness <7mm on the day of ET
  • Cesarean scar defect (isthmocele)

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
No Intervention: Control group
In the control group, the patients will be indicated with standard protocol, micronized progesterone (Cyclogest pessary) 400mg two times per day for 14 days, without any progesterone supplementation. If the beta-hcg test is positive, the patients will be treated with the same protocol and followed till 7 weeks of pregnancy when the fetal heart can be confirmed
Experimental: Study group
In the interventional group,the patients will be indicated with standard protocol, micronized progesterone (Cyclogest pessary) 400mg x 2 per day for 14 days, supplemented with intramuscular progesterone (Progesterone 25mg/ml) 25 mg x 2 at one time per day for 14 days. If the beta-hcg test is positive, the patients will be treated with the same protocol and followed till 7 weeks of pregnancy when the fetal heart can be confirmed
Procedure: Progesterone supplementation
This procedure is to add more progesterone on those who have low progesterone levels on the day of embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: week 11 - 14 of pregnancy
defined as the pregnancy completed 11 - 14 weeks of gestation and having vital fetus
week 11 - 14 of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implantation rate
Time Frame: 3 weeks after embryo transfer
the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period
3 weeks after embryo transfer
Pregnancy rate
Time Frame: 2 weeks after embryo transfer
beta-hCG test is positive
2 weeks after embryo transfer
clinical pregnancy rate
Time Frame: 3 weeks after embryo transfer
pregnancy when fetal heart can be confirmed
3 weeks after embryo transfer

Collaborators and Investigators

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

Sponsor

Tu Du Hospital

Investigators

  • Principal Investigator: Chau TM Le, Department of Infertility, Tu Du Hospital

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)

May 20, 2021

Primary Completion (Estimated)

May 20, 2024

Study Completion (Estimated)

June 20, 2024

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 18, 2021

First Posted (Actual)

May 21, 2021

Study Record Updates

Last Update Posted (Actual)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 656/BVTD-HDDD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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