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

NCT ID: NCT04408144

Last Updated: 2021-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-05-31

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.

Conditions

Infertility; IVF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

StudyGroup

Patients will receive an addition of dydrogesterone (Duphaston) to the standard treatment for luteal phase support

Group Type: EXPERIMENTAL

Dydrogesterone 10mg Oral Tablet

Intervention Type: DRUG

oral 10mg dydrogesterone (Duphaston) 2 times daily

Control Group

Patients will receive the standard treatment for luteal phase support without Dydrogesterone

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dydrogesterone 10mg Oral Tablet

oral 10mg dydrogesterone (Duphaston) 2 times daily

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Laniado Hospital

OTHER

Sponsor Role: lead

Responsible Party

Amir Weintraub

Director, IVF Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Laniado Hospital

Netanya, , Israel

Countries

Israel

Other Identifiers

0003-20-LND

Identifier Type: -

Identifier Source: org_study_id