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Completed

NCT Number: NCT04224818

Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders

This is a randomized controlled clinical trial to investigate the effect of dual trigger (hCG and GnRH agonist) on the final oocyte maturation compared to the standard hCG trigger in patients with poor ovarian reserve seeking IVF/ICSI treatment.

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Key information

Conditions

Poor Ovarian Reserve

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

American University of Beirut Medical Center

Beirut, Lebanon

About this study

Women with POR (Bologna criteria) manifest a very low follicular response to controlled ovarian stimulation irrespective of the stimulation protocol utilized. Dual triggering of oocyte maturation was shown to improve follicle collection yield and oocyte maturation in women with predicted normal ovarian response. These benefits have been attributed to the GnRHa-induced FSH surge believed to promote oocyte nuclear maturation and cumulus expansion. The aim of the study is to show whether the co-administration of a GnRH agonist and hCG for final oocyte maturation improve oocyte collection and maturation rate

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Normal uterine cavity (as assessed by hysteroscopy or HSG).
  • Normal hormonal investigation: TSH, PRL.
  • Low ovarian reserve patients (AMH<1.5ng/ml, AFC of 7 or less, 5 oocytes or less retrieved in a previous cycle)

Exclusion criteria

  • Abnormal uterine cavity (Hysteroscopy or HSG)
  • Evidence of untreated endocrine disorders (abnormal TSH, prolactin, testosterone and androstenedione concentrations)

Treatment and study plan

Dual trigger

Drug

Dual trigger: human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) + Gonadotropin-Releasing Hormone agonist (Triptorelin 0.3 mg subcutaneous once)

Other names: Dual ovulation trigger (Choriomon and Triptorelin)

hCG (standard)

Drug

human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once)

Other names: human Chorionic Gonadotropin

Primary outcomes

  1. Number of oocytes retrieved (oocyte collection rate)

    Time frame: 38 hrs

    the total number of oocytes retrieved divided by the number of follicles aspirated (diameter ≥10 mm) on the day of oocyte retrieval

  2. Number of mature oocytes (oocyte maturation rate)

    Time frame: 38 hrs

    the ratio of MII oocytes to the number of collected oocytes

Secondary outcomes

  1. Fertilization rate

    Time frame: 48 hrs

    the ratio of normal fertilized oocytes (2PN) to the number of oocytes used for fertilization

  2. Clinical pregnancy rate

    Time frame: 7 weeks

    the presence of fetal cardiac activity confirmed by transvaginal ultrasound 7 weeks after embryo transfer

  3. Implantation rate

    Time frame: 7 weeks

    the number of gestational sacs visualized on ultrasound examination divided by the number of embryos transferred

  4. Miscarriage rate

    Time frame: 12 weeks

    the spontaneous loss of a clinical pregnancy occurring before 12 completed weeks of gestational age

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders: A Prospective Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 13, 2020
Registry last updated
Jul 23, 2021

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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