The Value of Myomectomy in Women With Intramural Myoma Before IVF.

NCT ID: NCT03904368

Last Updated: 2019-04-05

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2020-12-31

Brief Summary

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Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention . 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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Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention .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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Fibroid Uterus IVF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Myomectomy group

women with intramural myoma not reaching endometrial cavity will undergo open myomectomy followed by ovarian stimulation for in vitro fertilization 6 months after the operation

Group Type ACTIVE_COMPARATOR

Open myomectomy

Intervention Type PROCEDURE

laparotomy then enucleation of the myoma followed by closure of the myometrial cavity

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 HCG triggering

Embryo transfer

Intervention Type PROCEDURE

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

Conservative group

women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization

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 HCG triggering

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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Open myomectomy

laparotomy then enucleation of the myoma followed by closure of the myometrial cavity

Intervention Type PROCEDURE

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 HCG triggering

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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Controlled Ovarian stimulation Ovulation triggering

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

18 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

Countries

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Egypt

Central Contacts

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Ahmed Maged, MD

Role: CONTACT

+201005227404

Other Identifiers

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55

Identifier Type: -

Identifier Source: org_study_id

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