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

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ClinicalTrials.gov Identifier: NCT03701490
Recruitment Status : Recruiting
First Posted : October 10, 2018
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

Tracking Information
First Submitted Date  ICMJE October 8, 2018
First Posted Date  ICMJE October 10, 2018
Last Update Posted Date August 6, 2020
Actual Study Start Date  ICMJE March 12, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Clinical pregnancy rate [ Time Frame: 4-5 weeks after progesterone treatment start. ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
Clinical pregnancy rate 4-5 weeks (V4) after progesterone treatment start. [ Time Frame: 4-5 weeks after progesterone treatment start. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • Serum progesterone level [ Time Frame: 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
  • Positive serum pregnancy (beta-hCG) test rate [ Time Frame: 19+/-2 days after start progesterone treatment ]
  • Implantation rate [ Time Frame: 4-5 weeks after start progesterone treatment. ]
  • Ongoing pregnancy rate [ Time Frame: 9-11 weeks after start progesterone treatment. ]
  • Abortion rate [ Time Frame: 9 months after start progesterone treatment. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2018)
  • Serum progesterone level [ Time Frame: 19+/-2 days and 4-5 weeks after start progesterone treatment ]
  • Uterine contractions [ Time Frame: on the day of Embryo transfer (i.e. 5 days after start progesterone treatment) ]
  • Positive beta-hCG test [ Time Frame: 19+/-2 days after start progesterone treatment ]
  • Implantation rate [ Time Frame: 4-5 weeks after start progesterone treatment. ]
  • Ongoing pregnancy rate [ Time Frame: 9-11 weeks after start progesterone treatment. ]
  • Abortion rate [ Time Frame: 9 months after start progesterone treatment. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prolutex in Frozen Embryo Transfer Cycles at the Blastocyst Stage (PROGEX)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Progesterone subcutaneous
    25 mg/twice a day.
  • Drug: Progesterone Vaginal Product
    200 mg three times a day.
Study Arms  ICMJE
  • Experimental: Prolutex
    Intervention: Drug: Progesterone subcutaneous
  • Experimental: Progeffik
    Intervention: Drug: Progesterone Vaginal Product
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 9, 2018)
212
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03701490
Other Study ID Numbers  ICMJE 18E-Prg06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party IBSA Institut Biochimique SA
Study Sponsor  ICMJE IBSA Institut Biochimique SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account IBSA Institut Biochimique SA
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP