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

Not Applicable

• Conditions: Infertility; IVF
• Interventions: Drug: Dydrogesterone 10mg Oral Tablet

• Registration Number: NCT04408144
• Lead Sponsor: Laniado Hospital

Brief 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.

Detailed Description

In the context of IVF treatment, it's a standard of care to use progesterone for endometrial synchronization and for luteal phase support after embryos transfer and until week 9-12 of pregnancy.

In Israel, as in most european countries, vaginal insert of Micronised Vaginal Progesterone (MVP) is mostly prescribed.

Dydrogesterone is a potent active progesterone receptor agonist that is well tolerated, orally administered and is considered to be sufficiently safe during pregnancy.

Based on recent publications, single oral dydrogesterone treatment seems to be a good option in clinical practice for luteal phase support in IVF cycles with fresh embryos transfer.

But, until now, there is no publication evaluating the effectiveness of an addition of Dydrogesterone to the standard of care.

The aim of the study is to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.

The trial is a randomized controlled study, open label. Participants will receive either standard treatment with an addition of oral 10mg dydrogesterone (Duphaston) 2 times daily or the standard treatment without Dydrogesterone, starting on the day of fresh embryos transfer until 10 weeks of gestation or until pregnancy test is negative.

Study participation will be proposed to every woman going through fresh embryos transfer in Laniado IVF unit, who meets the inclusion/exclusion criteria.

The investigators aim to include 150 patients in each arm of the study, during 2 years.

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-29
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-04
• Study Start: 2022-04-01
• Primary Completion: 2022-05-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
StudyGroup	Dydrogesterone 10mg Oral Tablet	Patients will receive an addition of dydrogesterone (Duphaston) to the standard treatment for luteal phase support

Primary Outcome Measures

Name	Time	Method
Live birth rate	9 month	The percentage of live newborns in the total cycles of treatment

Secondary Outcome Measures

Name	Time	Method
Rates of Newborn malformations	1 year	Abnormal findings of physical examination of the newborn
Presence of fetal heartbeats at 12 weeks of gestation	12 weeks	The percentage of pregnancies with heartbeats observed by ultrasound at 12 weeks in the total cycles of treatment
Rates of obstetrical complications	9 months	Obstetrical complications during pregnancy and labor. Examples- abruptio placenta, First trimester bleeding, Preterm Prelabor Rupture Of Membranes (PPROM), preterm labor
Newborn outcomes	1 year	Appearance, Pulse, Grimace, Activity and Respiration (APGAR) score- between 0-10. 10 is the best outcome. 0 is the worst outcome.
Frequency of positive pregnancy tests on Day 14 after embryo transfer	14 days
Newborn Weight	9 months	in grammes

Trial Locations

Locations (1)

Laniado Hospital; 🇮🇱 Netanya, Israel