Effect of Local Endometrial Injury on Pregnancy Outcomes During Ovulation Induction Cycles

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-09-30

Brief Summary

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The aim of this study is to detect whether or not performing an endometrial sampling in the cycle preceding ovulation induction with clomiphene citrate can improve pregnancy outcomes in the next cycle.

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Detailed Description

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Patients will be randomized using a list of computer generated random sample into two groups:

Group 1: Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.

Group 2: Couples who will undergo ovulation induction with clomiphene citrate. The drug chosen for ovulation induction in both groups will be clomephine citrate.

Timing and technique of endometrial sampling:

Timing: from day 15 to day 24 of the cycle preceding ovulation induction cycle. Technique: this will be done using the pipelle method (Williams et al., 2008).

The procedure is as follows:

1. Vaginal speculum to expose the uterine cervix then sterilization by saline.
2. The piston positioned at the extreme distal end of the sheath then the Pipelle is inserted gently through the cervical canal into the cavity of the uterus.
3. While holding the sheath in position with one hand, the other hand rapidly pulls the piston firmly and without interruption.
4. A negative pressure within the sheath will draw the tissue into the curette opening at the distal end of the sheath and captures the separated tissue within its lumen.

Conditions

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Asymptomatic Diseases

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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clomiphene and endometrial sampling

Couples who will undergo endometrial sampling in the luteal phase of the cycle preceding ovulation induction by clomiphene citrate.

Group Type ACTIVE_COMPARATOR

endometrial sampling

Intervention Type DEVICE

injury to the endometrium

clomiphene citrate

Intervention Type DRUG

ovulation induction by 100mg clomiphene citrate

clomiphene citrate

Couples who will undergo ovulation induction with clomiphene citrate.

Group Type ACTIVE_COMPARATOR

clomiphene citrate

Intervention Type DRUG

ovulation induction by 100mg clomiphene citrate

Interventions

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endometrial sampling

injury to the endometrium

Intervention Type DEVICE

clomiphene citrate

ovulation induction by 100mg clomiphene citrate

Intervention Type DRUG

Other Intervention Names

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clomid

Eligibility Criteria

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Inclusion Criteria

1. Male partner should have a normal semen count and motility according to world health organization criteria (Murray et al., 2012).
2. Primary, secondary or unexplained infertility for at least one year.
3. Failure to conceive with clomiphene citrate in spite of good follicular response for at least 3 cycles.
4. Age varies from 20-35 years with at least one year of infertility.
5. Body mass index between 19-30 kg/m2.
6. Day 2 serum FSH\< 12 IU/ml.
7. Normal uterine cavity on hystrosalpingography.
8. At least one patent tube of normal appearance on HSG.
9. No previous attempts of intrauterine insemination (IUI) or in vitro fertilization (IVF).

Exclusion Criteria

1. Infertility due to tubal factor or male factor.
2. Intrauterine organic pathology (myoma, polyp, adhesions) by hystrosalpingogram or diagnostic hysteroscope.
3. Hypogonadotrophic hypogonadism.

Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes