Prolutex in Frozen Embryo Transfer Cycles at the Blastocyst Stage (PROGEX) (PROGEX)

February 28, 2023 updated by: IBSA Institut Biochimique SA

A Proof of Concept, Randomized, Controlled Clinical Trial to Assess the Efficacy of Subcutaneous Progesterone (Prolutex) Versus Vaginal Progesterone (Progeffik) for Endometrial Preparation in Women Undergoing Frozen Embryo Transfer(FET) Cycles

The objective of this proof of concept clinical trial is to evaluate the impact of two different progesterone treatments for endometrial preparation (25 mg/twice-a-day, subcutaneous injection, and 200 mg/three times a day, vaginal administration) on the clinical pregnancy rate in women undergoing frozen embryo transfer (FET) at blastocyst stage.

Study Overview

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Phase 2

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

      • Alicante, Spain, 03016
        • Instituto Bernabeu
      • Sevilla, Spain, 41010
        • Ginemed

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 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women attending the clinics to undergo a frozen blastocyst embryo transfer, having given written informed consent, with the following characteristics:
  • 18-49 years of age for subjects undergoing ET with donated oocytes (both inclusive);
  • 18-37 years of age for subjects undergoing ET with autologous oocytes (both inclusive);
  • BMI <32 kg/m2;
  • Adequate endometrium preparation (Endometrial thickness > 7 mm) and E2 levels ( >100 pg/ml) on the day progesterone treatment is started;
  • P4 levels <1.5 ng/ml on the day progesterone treatment is started;
  • Transfer of 1 or 2 frozen embryos at blastocyst stage
  • Transfer of frozen embryos of quality A and/or B according to Gardner criteria1;
  • Semen from ejaculation either from the partner or from a bank
  • ≤ 3 previous ET (frozen and fresh) with no pregnancy
  • Normal uterine cavity (i.e. no polyp or protruding sub-mucosal fibroid).

Exclusion Criteria:

  • Presence of functional follicles > 10 mm of diameter on the day progesterone treatment is started;
  • Intramural uterine fibroids that distort the uterine cavity or polyps >1 cm;
  • Stage III or IV endometriosis (endometriomas);
  • Hydrosalpinx;
  • Pregnancy or lactation
  • Malformations of the sexual organs incompatible with pregnancy;
  • Patients affected by pathologies associated with any contraindication of being pregnant;
  • Known allergy to progesterone preparations or their excipients;
  • Uncontrolled adrenal or thyroid dysfunction;
  • Undiagnosed vaginal haemorrhage;
  • History of, or current arterial disease;
  • Patients with hepatic impairment;
  • HIV, Hepatitis B Virus or Hepatitis C Virus seropositive;
  • Neoplasias (current) or history of neoplasia that may be responsive to progesterone;
  • High grade cervical dysplasia;
  • Active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders;
  • Currently dependent on alcohol, drugs or psychotropic drugs
  • History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages wherein pregnancy developed to a minimum of a gestational sac on transvaginal ultrasonography;
  • Participation in a concurrent clinical trial or another trial within the past 2 months;
  • Use of concomitant medications that might interfere with the study evaluation: hormonal treatments other than those used in the study, except thyroid hormones.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prolutex
25 mg/twice a day.
Experimental: Progeffik
200 mg three times a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 4-5 weeks after progesterone treatment start.
4-5 weeks after progesterone treatment start.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum progesterone level
Time Frame: 19+/-2 days and 4-5 weeks after start progesterone treatment
19+/-2 days and 4-5 weeks after start progesterone treatment
Frequency of uterine contractions
Time Frame: on the day of Embryo transfer (i.e. 5 days after start progesterone treatment)
n of uterine contraction/min
on the day of Embryo transfer (i.e. 5 days after start progesterone treatment)
Positive serum pregnancy (beta-hCG) test rate
Time Frame: 19+/-2 days after start progesterone treatment
19+/-2 days after start progesterone treatment
Implantation rate
Time Frame: 4-5 weeks after start progesterone treatment.
4-5 weeks after start progesterone treatment.
Ongoing pregnancy rate
Time Frame: 9-11 weeks after start progesterone treatment.
9-11 weeks after start progesterone treatment.
Abortion rate
Time Frame: 9 months after start progesterone treatment.
9 months after start progesterone treatment.

Collaborators and Investigators

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

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)

March 12, 2019

Primary Completion (Actual)

September 28, 2022

Study Completion (Actual)

December 3, 2022

Study Registration Dates

First Submitted

October 8, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (Actual)

October 10, 2018

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

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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