COMPARING TWO PROTOCOLS FOR FINAL OOCYTE MATURATION IN POOR RESPONDERS UNDERGOING GnRH-ANTAGONIST ICSI CYCLES

NCT05397795 | Unknown Phase 3 FDA Drug

• 1 other identifier: DT193
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

Poor ovarian responders (POR) include a significant proportion of women referred for IVF treatments (ranging from 9 to 24 %), most of whom are in late reproductive age. In fact the live birth rate in the entire POR category is poor (about 6 % per cycle). However patients \<40 years have a significantly better prognosis compared to older patients, mainly due to better oocyte quality.Attempts to improve IVF cycle outcomes for poor responders included modifying the steps of ovarian stimulation protocols , such as different luteal phase pretreatments, increasing ovarian stimulation doses, as well as addition of various supplements. So far, most of the modifications had limited success, therefore, optimal protocol for poor responders has remained elusive. Final oocyte maturation trigger is one of the most important key success factors in assisted reproductive technologies (ARTs). Oocyte maturation refers to a release of meiotic arrest that allows oocytes to advance from prophase I to metaphase II of meiosis. Luteinizing Hormone (LH) surge by dismantling the gap junctions between granulosa cells and oocyte inhibits the flow of maturation inhibitory factors into ooplasm and causes drop in concentration of cAMP. Decreased concentration of cyclic AMP (cAMP) in turn increases concentration of Ca and maturation-promoting factor (MPF), which are essential for the resumption of meiosis in oocyte and disruption of oocyte-cumulus complex triggering follicular rupture and ovulation about 36 h the LH surge. The aim of the study is to compare the oocyte yield , oocyte quality and the ongoing pregnancy rate between dual trigger treatment (combination of gonadotrophin-releasing hormone (GnRH) agonist and human chorionic gonadotrophin) and human chorionic gonadotrophin alone in PORs undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF-ICSI) cycles using a GnRH-antagonist protocol.

Conditions

Infertility

Keywords

Oocyte Maturation; ICSI; poor responders; Trigger; Dual Trigger

Outcome Measures

Primary Outcomes (1)

• Number of metaphase II oocytes retrieved.

  Number of metaphase II oocytes retrieved

  On 1 day of oocyte retrieval

Secondary Outcomes (13)

• Total number of oocytes

  On 1 day of oocyte retrieval

• Ratio between number of follicles seen on day of trigger and number of oocytes retrieved

  On 1 day of oocyte retrieval

• Maturity index

  On 1 day of oocyte retrieval

• Fertilization rate

  On 1 day after oocyte retrieval

• Cancellation rate

  Folliculometry on day 8 revealed no growing follicles, serum estradiol level less than 150 pg/mL on the day of hCG administration, no oocytes were retrieved, or if fertilization failed

Study Arms (2)

Group(A)

EXPERIMENTAL

subjects will be triggered by 10000 IU of hCG (Choriomon5000 IU; IBSA) given intramuscularly.

Drug: 10000 IU hCG (Choriomon5000 IU; IBSA)

Group(B)

EXPERIMENTAL

subjects will be triggered by 10000 IU of hCG (Choriomon5000 IU; IBSA) intramuscular injection in addition to the GnRH agonist triptorelin 0.2 mg (Decapeptyl 0.1 mg; Ferring) subcutaneously.

Drug: 10000 IU hCG (Choriomon5000 IU; IBSA); Drug: Triptorelin 0.2 mg (Decapeptyl 0.1 mg; Ferring)

Interventions

10000 IU hCG (Choriomon5000 IU; IBSA) DRUG

10000 IU of hCG (Choriomon5000 IU; IBSA) given intramuscularly

Also known as: CHORIONIC GONADOTROPHIN 5000 U

Group(A); Group(B)

Triptorelin 0.2 mg (Decapeptyl 0.1 mg; Ferring) DRUG

GnRH agonist triptorelin 0.2 mg (Decapeptyl 0.1 mg; Ferring) subcutaneously.

Also known as: TRIPTOFEM 0.1 mg

Group(B)

Eligibility Criteria

• Age: 19 Years - 45 Years
• Gender Eligibility Details: Female In Reproductive Age group
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with a spontaneous normal menstrual cycle and a normal uterine cavity.
• Body mass index (BMI) \< 35.
• Age less than 45.
• Anti-Mullerian Hormone (AMH) ≤ 1.1 ng/ ml
• Antral Follicle Count (AFC) ≤ 7 follicles

You may not qualify if:

• Comorbidities including, hypertension, Diabetes Mellitus or other endocrinopathies.
• Surgically retrieved sperms.
• Communicating hydrosalpinx.

Sponsors & Collaborators

• Alexandria University: lead

Related Publications (1)

• Ding N, Liu X, Jian Q, Liang Z, Wang F. Dual trigger of final oocyte maturation with a combination of GnRH agonist and hCG versus a hCG alone trigger in GnRH antagonist cycle for in vitro fertilization: A Systematic Review and Meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2017 Nov;218:92-98. doi: 10.1016/j.ejogrb.2017.09.004. Epub 2017 Sep 14.

  PMID: 28957685 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin; Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Neuropeptides; Oligopeptides; Nerve Tissue Proteins

Study Officials

• Mervat Sh EL-Arab, MDPhD

  mervatsheikhelarab@gmail.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elsayed Ah Ahmed, Master

CONTACT

2001001438244; elsayed.ahmed549@gmail.com

Ahmed Al Abdelkreem, Master

CONTACT

2001033146216; elsayed.ahmed5499@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before enrollment in the study, all patients will be subjected to routine medical evaluation to make sure of presence of inclusion criteria and absence of exclusion criteria. Then women will be randomized using computer-based randomization (Random Digit Software). All included women will undergo a fixed GnRH antagonist protocol of COH. At the day of triggering, number of follicles and the number of oocytes expected to be retrieved will be documented and women will be given the trigger according to the randomization done at the enrollment. Two main groups will be created depending on the trigger protocol used: Group A: 80 subjects will be triggered by 10000 IU of hCG (Choriomon5000 IU; IBSA) given intramuscularly. Group B: 80 subjects will be triggered by 10000 IU of hCG (Choriomon5000 IU; IBSA) intramuscular injection in addition to the GnRH agonist triptorelin 0.2 mg (Decapeptyl 0.1 mg; Ferring) subcutaneously.

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: May 31, 2022
• Study Start: June 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Just after completion of the study and the data will be open accessed
• Access Criteria: web address and journals