Skip to content

Different routes of progesterone administration for sustaining implantation in in vitro fertilisation patients: impact on pregnancy and live birth rates

Oral dydrogesterone associated with vaginal micronized progesterone supplementation vs vaginal micronized progesterone alone supplementation for luteal phase support in in vitro fertilization patients: effects on pregnancy and live birth rates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN52148405
Enrollment
650
Registered
2023-08-15
Start date
2017-01-01
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Luteal phase supplementation in assisted reproduction Pregnancy and Childbirth

Interventions

All the patients are going to have a mild ovarian stimulation protocol: rFSH will be started at a dose of 75-150 IU on the base of AMH level. GnRH antagonist (0.25 mg/day) will be administered when t
Group B will receive a combination of vaginal administration of a gel of micronized progesterone (90 mg/day) and oral dydrogesterone 10 mg twice a day for luteal phase support. The duration of the tre
follow-up will be around 9 months for each patient, from the established pregnancy to the delivery.

Sponsors

One Day Medical Center srl
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Infertility attributable to tubal factors, moderate endometriosis, male factor, or idiopathic infertility 2. Serum hormonal profile within the normal range (AMH >1 ng/ml) 3. Regular menstrual cycles 4. The presence of a normal uterine cavity 5. Body mass index (BMI) of 20–26 kg/m²

Exclusion criteria

Exclusion criteria: 1. Infertility attributable to genetic factors or severely reduced ovarian reserve 2. Serum hormonal profile showing a reduced ovarian reserve (AMH 26 kg/m²

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy measured using a blood test to evaluate the level of human chorionic gonadotropin (hCG), which indicates the eventual embryo implantation and pregnancy, 14 days after embryo replacement in the patient's uterus

Secondary

MeasureTime frame
Embryo implantation rate measured using ultrasonography at 4 weeks following a positive hCG test to confirm the clinical pregnancy

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026