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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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
Infertility Drug: Progesterone subcutaneous Drug: Progesterone Vaginal Product Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 12, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 4-5 weeks after progesterone treatment start. ]

Secondary Outcome Measures :
  1. Serum progesterone level [ Time Frame: 19+/-2 days and 4-5 weeks after start progesterone treatment ]
  2. 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

  3. Positive serum pregnancy (beta-hCG) test rate [ Time Frame: 19+/-2 days after start progesterone treatment ]
  4. Implantation rate [ Time Frame: 4-5 weeks after start progesterone treatment. ]
  5. Ongoing pregnancy rate [ Time Frame: 9-11 weeks after start progesterone treatment. ]
  6. Abortion rate [ Time Frame: 9 months after start progesterone treatment. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701490


Locations
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Spain
Instituto Bernabeu Not yet recruiting
Alicante, Spain, 03016
Contact: Joaquín Llácer, MD    +34 965 154 000    jllacer@institutobernabeu.com   
Ginemed Recruiting
Sevilla, Spain, 41010
Contact: Pascual Sánchez, MD    +34 954 991 051    psanchez@ginemed.es   
Sponsors and Collaborators
IBSA Institut Biochimique SA
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Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT03701490    
Other Study ID Numbers: 18E-Prg06
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs