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

NCT04408144 | Unknown

• 1 other identifier: 0003-20-LND
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; IVF

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  The percentage of live newborns in the total cycles of treatment

  9 month

Secondary Outcomes (6)

• Presence of fetal heartbeats at 12 weeks of gestation

  12 weeks

• Frequency of positive pregnancy tests on Day 14 after embryo transfer

  14 days

• Rates of obstetrical complications

  9 months

• Newborn outcomes

  1 year

• Newborn Weight

  9 months

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  3 years

Study Arms (2)

StudyGroup

EXPERIMENTAL

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

Drug: Dydrogesterone 10mg Oral Tablet

Control Group

NO INTERVENTION

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

Interventions

Dydrogesterone 10mg Oral Tablet DRUG

oral 10mg dydrogesterone (Duphaston) 2 times daily

StudyGroup

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Laniado Hospital: lead

Study Sites (1)

Laniado Hospital

Netanya, Israel

Location

MeSH Terms

Conditions

Infertility

Interventions

Dydrogesterone; Tablets

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, IVF Unit

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 29, 2020
• Study Start: April 1, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2023
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

IL (1)