Addition of Dydrogesterone to the Luteal Phase Support After Fresh Embryo Transfer

• Status: Not yet recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: Female

Summary

Randomized controlled study, open label to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Laniado Hospital
• Treatments: Dydrogesterone

Criteria

Inclusion Criteria:

• Patients with a documented history of infertility who underwent IVF with or without ICSI, going through embryos transfer (having in the past up to 2 previous embryos transfer) and who gave written informed consent.

• Body mass index ≥18 to ≤35 kg/m2

• LH, prolactin (PRL), testosterone and thyroid-stimulating hormone (TSH) within normal clinical limits or not considered clinically significant within 1 year prior to or at screening

• Normal transvaginal ultrasound at screening (or within 14 days prior to screening)

• Planning a transfer of 1 or 2 fresh embryos.

Exclusion Criteria:

• Previous participation in this trial

• Subjects with >2 unsuccessful IVF attempts

• Evidence of head, ear, eye, nose, throat, cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine or neurologic/psychiatric disorders;

• Recent major surgery (within 3 months);

• Current or recent substance abuse, including that of alcohol and tobacco;

• History of chemotherapy;

• History of recurrent pregnancy loss (≥3 previous miscarriages)