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

  • End date
    Apr 19, 2023
  • participants needed
  • sponsor
    IBSA Institut Biochimique SA
Updated on 4 October 2022
embryo transfer


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


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)
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note