search
Back to results

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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Progesterone subcutaneous
Progesterone Vaginal Product
Sponsored by
IBSA Institut Biochimique SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Instituto Bernabeu
  • Ginemed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Prolutex

Progeffik

Arm Description

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

Secondary Outcome Measures

Serum progesterone level
Frequency of uterine contractions
n of uterine contraction/min
Positive serum pregnancy (beta-hCG) test rate
Implantation rate
Ongoing pregnancy rate
Abortion rate

Full Information

First Posted
October 8, 2018
Last Updated
February 28, 2023
Sponsor
IBSA Institut Biochimique SA
search

1. Study Identification

Unique Protocol Identification Number
NCT03701490
Brief Title
Prolutex in Frozen Embryo Transfer Cycles at the Blastocyst Stage (PROGEX)
Acronym
PROGEX
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 12, 2019 (Actual)
Primary Completion Date
September 28, 2022 (Actual)
Study Completion Date
December 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IBSA Institut Biochimique SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolutex
Arm Type
Experimental
Arm Title
Progeffik
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Progesterone subcutaneous
Intervention Description
25 mg/twice a day.
Intervention Type
Drug
Intervention Name(s)
Progesterone Vaginal Product
Intervention Description
200 mg three times a day.
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Time Frame
4-5 weeks after progesterone treatment start.
Secondary Outcome Measure Information:
Title
Serum progesterone level
Time Frame
19+/-2 days and 4-5 weeks after start progesterone treatment
Title
Frequency of uterine contractions
Description
n of uterine contraction/min
Time Frame
on the day of Embryo transfer (i.e. 5 days after start progesterone treatment)
Title
Positive serum pregnancy (beta-hCG) test rate
Time Frame
19+/-2 days after start progesterone treatment
Title
Implantation rate
Time Frame
4-5 weeks after start progesterone treatment.
Title
Ongoing pregnancy rate
Time Frame
9-11 weeks after start progesterone treatment.
Title
Abortion rate
Time Frame
9 months after start progesterone treatment.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Instituto Bernabeu
City
Alicante
ZIP/Postal Code
03016
Country
Spain
Facility Name
Ginemed
City
Sevilla
ZIP/Postal Code
41010
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs