Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of Ovarian Response in Obese Women Undergoing IVF/ICSI Treatment

NCT03684824 | Unknown DMC

• 1 other identifier: 39
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

After detailed history and examination, long luteal protocol will be used for controlled ovarian hyperstimulation, so the patient will start treatment in day 21 of previous cycle, then in the early follicular phase of next cycle day 2-3 will have transvaginal sonography for assessment of total ovarian volume and number of antral follicles measuring (2-10mm) in diameter. On the same day a venous sample will be obtained for the measurement of AMH, basal FSH and E2 levels

Conditions

Invitro Fertilization

Outcome Measures

Primary Outcomes (1)

• number of retrieved oocytes

  number of oocytes retrieved at day of ovum pick up

  34 hours after HCG triggering of ovulation

Secondary Outcomes (1)

• Clinical pregnancy rate

  14 days after embryo transfer

Study Arms (1)

obese group

OTHER

100 obese patients with BMI between 30 and 35 who are undergoing IVF/ICSI treatment for infertility

Drug: Long luteal phase GnRH agonist protocol; Drug: Gonadotropins

Interventions

Long luteal phase GnRH agonist protocol DRUG

Pituitary suppression will be done using daily subcutaneous injection of triptorelin acetate ( Decapeptyl 0.1mg, Ferring, Germany). Starting from day 21 of the previous cycle

Also known as: Decapeptyl 0.1mg amp

obese group

Gonadotropins DRUG

Controlled ovarian hyperstimulation will be done using daily intramuscular injection of highly purified Human Menopausal Gonadotrophins (Merional 75 IU/ml, IBSA, Switzerland), starting from day 2-3 of the stimulated cycle, total dose will be adjusted according to patient response

Also known as: Merional 75 IU/ml, IBSA, Switzerland

obese group

Eligibility Criteria

• Age: 19 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women between 20 and 35 age.
• BMI: 30 -35

You may not qualify if:

• Women less than 19 years or more than 35 years.
• BMI less than 30 or more than 35
• Women with Hypothyroidism.
• Women receiving any treatment may reduce their fertility e.g: chemotherapy.
• Women with recurrent IVF failure

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ameer Elsherief

Minya, Egypt

Location

MeSH Terms

Interventions

Triptorelin Pamoate; Adenosine Monophosphate; Gonadotropins; hMG-IBSA

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Ahmed maged

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed maged, MD

CONTACT

+2001005227404; prof.ahmedmaged@gmail.com

Ameer Elsherief, MD

CONTACT

ameerelsherief@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 26, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 26, 2018

Record last verified: 2018-09

Locations

EG (1)