Infertility
Conditions
Brief 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.
Interventions
DRUGProgesterone subcutaneous
25 mg/twice a day.
200 mg three times a day.
Sponsors
IBSA Institut Biochimique SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rate | 4-5 weeks after progesterone treatment start. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Serum progesterone level | 19+/-2 days and 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. | — |
| Implantation rate | 4-5 weeks after start progesterone treatment. | — |
Countries
Spain
Outcome results
None listed