HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome

NCT05969834 | Completed

• 1 other identifier: MD.20.09.370
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to assess the correlation between HCG levels after ovulation triggering and ICSI outcomes, affected by HCG formulation and dose

Conditions

Infertility

Keywords

Ovulation triggering; uHCG; rHCG; GnRH; Dual trigger

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures

  6 weeks after embryo transfer

Secondary Outcomes (1)

• Oocyte maturation rate

  On 1 day of oocyte retrieval

Study Arms (3)

uHCG group

Trigger intramuscular (IM) administration of 10000 IU of uHCG

Drug: uHCG

rHCG group

Trigger with subcutaneous (SC) administration of 6500 IU of rHCG

Drug: rHCG

Dual trigger group

Combined SC administration of 0.1 mg of GnRHa and IM administration of 2500 IU of uHCG

Drug: uHCG and GnRHa

Interventions

uHCG DRUG

Final oocyte maturation will be triggered by IM administration of 10000 IU of uHCG (Choriomon)

Also known as: Choriomon

uHCG group

rHCG DRUG

Final oocyte maturation will be triggered by SC administration of 6500 IU of rHCG (Ovitrelle)

Also known as: Ovitrelle

rHCG group

uHCG and GnRHa DRUG

Final oocyte maturation will be triggered by combined SC administration of 0.1 mg of GnRHa (Decapeptyl, Triptorelin) and IM administration of 2500 IU of uHCG (Choriomon)

Also known as: Decapeptyl and Choriomon

Dual trigger group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol with ovulation triggering, according to the risk of OHSS, by: 1) urinary HCG (uHCG); 2) recombinant HCG (rHCG); or 3) a combination of GnRHa and HCG (dual trigger)

You may qualify if:

• Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist protocol

You may not qualify if:

• BMI \> 30 kg/m2
• Irregular menstruation
• Severe male factor abnormality
• Poor ovarian reserve
• Endometriosis
• Uterine abnormality

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Royal Center

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

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

• Engy Abdallah, MSc

  Mansoura University

  PRINCIPAL INVESTIGATOR

• Mohamed S Abdelhafez, MD

  Mansoura University

  STUDY DIRECTOR

• Mohamed Elzayat, MD

  Royal Center

  STUDY CHAIR

• Amoura Abou-ElNaga, MD

  Mansoura University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: March 31, 2021
• Primary Completion: July 19, 2022
• Study Completion: August 7, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

EG (1)