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Completed

NCT Number: NCT04356105

Protocols of IVF/ICSI in Poor Responders

Comparing two ovarian induction protocols in poor responders in IVF/ICSI cycles

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Urogenital Diseases

Age range

30 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Cairo University, Cairo, Egypt

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About this study

The two groups of poor responders are randomized into either; a minimal dose stimulation protocol involving letrozole, recombinant FSH and GnRH antagonist versus a microflare conventional protocol with OCP, GnRH agonist and high dose recombinant FSH, in their IVF/ICSI cycles, primary outcome will be the number of oocytes retrieved.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1- More than 1 year of infertility 2 - Poor ovarian responder according to the Bologna criteria:

  • Advanced maternal age
  • Previous poor ovarian response
  • Abnormal tests of ovarian reserve (AFC < 5-7, AMH <0.5-1.1 ng/ml)

Exclusion criteria

  • Age > 43 years
  • baseline FSH >15 mIU/ml
  • Previous ovarian surgery
  • Ovarian endometrioma
  • Uterine anomaly or myoma
  • Any medical disorder
  • Any hormonal disorder eg. hyperprolactinemia
  • BMI > 30 kg/m2
  • Severe male factor

Treatment and study plan

Minimal stimulation protocol

Drug

Letrozole, Recombinant FSH, GnRH antagonist

Other names: Ovarian induction protocol

Microflare protocol

Drug

OCP, GnRH agonist, Recombinant FSH

Other names: Ovarian induction protocol

IVF/ICSI cycle

Procedure

Involving ovum pickup and embryo transfer

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: 10 to 14 days

    the number of oocytes collected from each participants in the two groups on the day of ovum pickup

Secondary outcomes

  1. Number of MII oocytes retrieved

    Time frame: 10 to 14 days

    The mature oocytes colloected on the day of ovum pickup

  2. Number of fertilized oocytes

    Time frame: 2 days

    Number of oocytes fertilized

  3. Number of embryos transferred

    Time frame: Day 3 after ovum pickup

    Number of embryos transferred in the induction cycle

  4. Number of embryos cryopreserved

    Time frame: Day 3 after ovum pickup

    Any surplus good quality embryos available for cryopreservation

  5. Chemical pregnancy rate

    Time frame: 14 days after embryo ransfer

    Positive pregnancy test

  6. Clinical pregnancy rate

    Time frame: 5 to 7 weeks after embryo transfer

    Positive heart beat

  7. Early miscarriage rate

    Time frame: 12 weeks

    loss of pregnancy before 12 weeks

  8. Ongoing pregnancy rate

    Time frame: 12 weeks

    pregnancy beyond 12 weeks

  9. Live birth rate

    Time frame: 28 to 40 weeks

    Delivery beyond 28 weeks

Other outcomes

  1. Cancellation rate

    Time frame: 10 to 14 days

    Number of cycles not reaching ovum pickup

  2. Total dose of recombinant FSH

    Time frame: 10 to 14 days

    The mean total dose of recombinant FSH used in the cycle of treatment

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Minimal Stimulation in a Combined Letrozole Antagonist Protocol Versus Microflare Protocol in Poor Responders Undergoing Invitrofertilization/ Intracytoplasmic Sperm Injection; Randomized Parallel Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 22, 2020
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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