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

  • STATUS
    Recruiting
  • End date
    Apr 19, 2023
  • participants needed
    212
  • sponsor
    IBSA Institut Biochimique SA
Updated on 4 October 2022
cavities
progesterone
leiomyoma
prostanoids
embryo transfer

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.

Details
Condition Infertility
Treatment Progesterone subcutaneous, Progesterone Vaginal Product
Clinical Study IdentifierNCT03701490
SponsorIBSA Institut Biochimique SA
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Women attending the clinics to undergo a frozen blastocyst embryo transfer, having given written informed consent, with the following characteristics
-49 years of age for subjects undergoing ET with donated oocytes (both inclusive)
-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
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