Effects of Intramural Fibroids on IVF Outcome

Effects of Intramural Fibroids That do Not Distort the Uterine Cavity on IVF Outcome

A cohort study involving 200 women candidate for IVF / ICSI cycles . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts.

On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH),

, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.

Study Overview

• Status: Recruiting
• Conditions: Infertility, Female; Assisted Reproduction
• Intervention / Treatment: Drug: Gonadotropins; Drug: human chorionic gonadotropin; Procedure: Ovum pick up; Procedure: Embryo transfer

Detailed Description

A cohort study involving 200 women candidate for IVF / ICSI cycles . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts.

On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH),

, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Maged, MD; Phone Number: +201005227404; Email: prof.ahmedmaged@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 12151
    • Recruiting
    • Kasr Alainy medical school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• age younger than 40 years
• FSH) less than 10 IU/L
• serum prolactin level normal
• uterine cavity abnormality was excluded by hysteroscopy or hysterosalpingography.

Exclusion Criteria:

• abnormal endocrine function (e.g. abnormal thyroid or adrenal function)
• ovarian cysts,
• hydrosalpinx
• endometrial polyps
• male partner with azoospermia
• ICSI performed for preimplantation genetic diagnosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fiboroid group; Women with intramural myoma no reaching the cavity	Drug: Gonadotropins; Gonadotropin stimulation of follicular growth; Other Names: Ovarian stimulation; Drug: human chorionic gonadotropin; HCG triggering of ovulation; Other Names: Triggering of ovulation; Procedure: Ovum pick up; 34 to 36 hours after oocyte retrieval; Procedure: Embryo transfer; Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval
Active Comparator: Non fibroid group; Women without myomas	Drug: Gonadotropins; Gonadotropin stimulation of follicular growth; Other Names: Ovarian stimulation; Drug: human chorionic gonadotropin; HCG triggering of ovulation; Other Names: Triggering of ovulation; Procedure: Ovum pick up; 34 to 36 hours after oocyte retrieval; Procedure: Embryo transfer; Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	appearance of one or more intrauterine gestational sac	4 weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: March 31, 2019
• First Submitted That Met QC Criteria: April 3, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 30, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Reproductive Control Agents; Chorionic Gonadotropin
• Other Study ID Numbers: 54

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No