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

Sponsor
IBSA Institut Biochimique SA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03701490
Collaborator
(none)
212
Enrollment
2
Locations
2
Arms
48.7
Anticipated Duration (Months)
106
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Progesterone subcutaneous
  • Drug: Progesterone Vaginal Product
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
212 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 12, 2019
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prolutex

Drug: Progesterone subcutaneous
25 mg/twice a day.
Experimental: Progeffik

Drug: Progesterone Vaginal Product
200 mg three times a day.

Outcome Measures

Primary Outcome Measures

  1. Clinical pregnancy rate [4-5 weeks after progesterone treatment start.]

Secondary Outcome Measures

  1. Serum progesterone level [19+/-2 days and 4-5 weeks after start progesterone treatment]

  2. Frequency of uterine contractions [on the day of Embryo transfer (i.e. 5 days after start progesterone treatment)]

    n of uterine contraction/min

  3. Positive serum pregnancy (beta-hCG) test rate [19+/-2 days after start progesterone treatment]

  4. Implantation rate [4-5 weeks after start progesterone treatment.]

  5. Ongoing pregnancy rate [9-11 weeks after start progesterone treatment.]

  6. Abortion rate [9 months after start progesterone treatment.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Instituto Bernabeu Alicante Spain 03016
2 Ginemed Sevilla Spain 41010

Sponsors and Collaborators

  • IBSA Institut Biochimique SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT03701490
Other Study ID Numbers:
  • 18E-Prg06
First Posted:
Oct 10, 2018
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility
Progesterone

Study Results

No Results Posted as of Aug 3, 2022