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

Effectiveness of Treatment With Additional Dydrogesterone (Duphaston) to the Standard Luteal Phase Support After Fresh Embryo Transfer: a Prospective Randomized Controlled Trial.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility; IVF
• Intervention / Treatment: Drug: Dydrogesterone 10mg Oral Tablet

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Netanya, Israel
    • Laniado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: StudyGroup; Patients will receive an addition of dydrogesterone (Duphaston) to the standard treatment for luteal phase support	Drug: Dydrogesterone 10mg Oral Tablet; oral 10mg dydrogesterone (Duphaston) 2 times daily
No Intervention: Control Group; Patients will receive the standard treatment for luteal phase support without Dydrogesterone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth rate	The percentage of live newborns in the total cycles of treatment	9 month

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Adverse Events (AES) and Serious Adverse Events (SAES) will be recorded during all the study period	3 years

Collaborators and Investigators

• Sponsor: Laniado Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): May 31, 2022
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 25, 2020
• First Posted (Actual): May 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Dydrogesterone
• Other Study ID Numbers: 0003-20-LND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No