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

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IBSA Institut Biochimique SA
• Treatments: Progesterone

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.