se of Prolutex in frozen embryo transfer cycles at the blastocyst stage.

Phase 1

• Conditions: Infertility. Assisted Reproductive Tecniques.; MedDRA version: 20.0 Level: LLT Classification code 10073184 Term: Embryo transfer System Organ Class: 100000004865; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2018-002897-27-ES
• Lead Sponsor: IBSA, Institut Biochimique, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-18
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 212

Inclusion Criteria

•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 inclu-sive);
•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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 212
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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;
•Subjects affected by pathologies associated with any contraindication of being preg-nant;
•Known allergy to progesterone preparations or their excipients;
•Uncontrolled adrenal or thyroid dysfunction;
•Undiagnosed vaginal haemorrhage;
•History of, or current arterial disease;
•Subjects with hepatic impairment;
•Human Immunodeficiency Virus, 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 TVUS;
•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: hor-monal treatments other than those used in the study, except thyroid hormones.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified