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

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Prolutex	Progesterone subcutaneous	-
Progeffik	Progesterone Vaginal Product	-

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	4-5 weeks after progesterone treatment start.

Secondary Outcome Measures

Name	Time	Method
Serum progesterone level	19+/-2 days and 4-5 weeks after start progesterone treatment
Frequency of uterine contractions	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	19+/-2 days after start progesterone treatment
Implantation rate	4-5 weeks after start progesterone treatment.
Ongoing pregnancy rate	9-11 weeks after start progesterone treatment.
Abortion rate	9 months after start progesterone treatment.

Recruitment & Eligibility