Effects of Intramural Fibroids on IVF Outcome

NCT ID: NCT03904355

Last Updated: 2021-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2022-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility, Female Assisted Reproduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Fiboroid group

Women with intramural myoma no reaching the cavity

Group Type ACTIVE_COMPARATOR

Gonadotropins

Intervention Type DRUG

Gonadotropin stimulation of follicular growth

human chorionic gonadotropin

Intervention Type DRUG

HCG triggering of ovulation

Ovum pick up

Intervention Type PROCEDURE

34 to 36 hours after oocyte retrieval

Embryo transfer

Intervention Type PROCEDURE

Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval

Non fibroid group

Women without myomas

Group Type ACTIVE_COMPARATOR

Gonadotropins

Intervention Type DRUG

Gonadotropin stimulation of follicular growth

human chorionic gonadotropin

Intervention Type DRUG

HCG triggering of ovulation

Ovum pick up

Intervention Type PROCEDURE

34 to 36 hours after oocyte retrieval

Embryo transfer

Intervention Type PROCEDURE

Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval

Interventions

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Gonadotropins

Gonadotropin stimulation of follicular growth

Intervention Type DRUG

human chorionic gonadotropin

HCG triggering of ovulation

Intervention Type DRUG

Ovum pick up

34 to 36 hours after oocyte retrieval

Intervention Type PROCEDURE

Embryo transfer

Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval

Intervention Type PROCEDURE

Other Intervention Names

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Ovarian stimulation Triggering of ovulation

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Maged, MD

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Maged, MD

Role: CONTACT

+201005227404

Facility Contacts

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Ahmed Maged, MD

Role: primary

01005227404

Other Identifiers

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54

Identifier Type: -

Identifier Source: org_study_id

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