Oestradiol Supplementation in Luteal Long Agonist Fresh In Vitro Fertilization/Intra Cytoplasmic Sperm Injection ( IVF/ICSI) Cycle .

NCT03832894 | Unknown Phase 3

• 1 other identifier: MD IVF
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Whether oestradiol administration affects the pregnancy rate in long agonist fresh IVF/ICSI cycles. Oestradiol level will be measured the day of HCG trigger to assess whether oestradiol level affects cycle outcome results.

Conditions

Infertility

Keywords

IVF; ICSI; oestradiol; long protocol

Outcome Measures

Primary Outcomes (1)

• Implantation rate

  Number of gestational sacs per number of embryos transferred per cycle

  4 weeks after embryo transfer of each enrolled patient

Secondary Outcomes (3)

• Chemical pregnancy rate

  Two weeks after embryo transfer of each enrolled patient

• Clinical pregnancy rate

  4 weeks after embryo transfer of each enrolled patient with positive pregnancy test or 6 weeks from IVF cycle beginning in pregnant patients

• Ongoing pregnancy rate

  10 weeks after embryo transfer of each enrolled patient or 12 weeks from starting IVF cycle in pregnant patients

Study Arms (2)

Group receiving oestradiol tablets in addition to progesterone

ACTIVE COMPARATOR

Group A :Will receive 400mg progesterone in the form of vaginal or rectal suppositories in addition to estradiol valerate oral tablets in a dose of 4mg/day(2x2), for luteal phase support. Starting from the day of ovum pickup and for 14 days after embryo transfer. Group B : Will receive a dose of 400mg progesterone in the form of vaginal or rectal suppositories in addition to 2 placebo oral tablets(similar to estrogen tablets) for luteal phase support, from the day of Ovum pickup and for 14 days after embryo transfer.

Drug: Estradiol Valerate

Group not receiving oestradiol tablets.

PLACEBO COMPARATOR

Group B : Will receive a dose of 400mg progesterone in the form of vaginal or rectal suppositories in addition to 2 placebo oral tablets(similar to estrogen tablets) for luteal phase support, from the day of Ovum pickup and for 14 days after embryo transfer

Drug: Estradiol Valerate

Interventions

Estradiol Valerate DRUG

Oestradiol supplementation starting from day of trigger through out the luteal phase

Also known as: Progynova, Progesterone vaginal suppositories

Group not receiving oestradiol tablets.; Group receiving oestradiol tablets in addition to progesterone

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age group 20-38 years old.
• Patients Undergoing gonadotropin Releasing Hormone (Gn RH) long agonist protocol, with fresh embryo transfer.
• Day 3 Grade 1 embryos.
• Trilamellar endometrium with ranging endometrial thickness from 8 mm to 14 mm.

You may not qualify if:

• Karyotypic abnormalities in either partner.
• Patients with uterine abnormalities.
• G3-G4 quality embryos.
• Estradiol level 10,000 or more at time of trigger.
• Cases of egg donation/sperm donation/embryo donation.
• Polycystic ovary syndrome (PCOS )patients.
• Poor responders (maternal age \>40, Antral follicle counts (AFC )\<5, Anti Mullerian Hormone (AMH )\<1 and previous trial \<5 oocyte retrieved ) (bologna criteria 2011)
• Those with 3 or more implantation failure.
• Endometrial thickness \<8 or \>14mm.
• Severe male factor.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Art Unit/ Obatetrics and Gynecology Department

Cairo, Cair0, 11542, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

SHERINE HOSNY

CONTACT

01097665573; sherinehosny@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization will be held by using the computer generated randomization codes, which will then be placed in the sealed envelopes by a third party (nurse). Each patient will choose a sealed envelope containing randomization number either group A or B. Both participant and health provider will be blinded to patients grouping
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 6, 2019
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 7, 2019

Record last verified: 2019-02

Locations

EG (1)