Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility

Ain Shams Maternity Hospital

Status: Unknown

Conditions: Infertility; Ovarian Hyperstimulation; Pregnancy; Primary Infertility Unspecified

Treatments: Device: Hysteroscope; Procedure: Hysteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02416596

ASMH-RH1

Details and patient eligibility

About

The aim of the present study is to evaluate the impact of hysteroscopy prior to starting the IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary infertility.

Full description

Proper history, examination and investigations are carried out to diagnose causes of infertility. Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle using a rigid hysteroscope. Controlled ovarian hyper stimulation-embryo transfer (COH-ET) using the standard long protocol of induction used in Ain Shams University Maternity Hospitals ART (assisted reproductive techniques) unit.

Biochemical pregnancy will be determined by a positive pregnancy test performed 2 weeks after embryo transfer and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after embryo transfer.

Enrollment: 680 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing IVF/ICSI using the standard long GnRH-a (gonadotropin-releasing hormone-a) protocol.
• No evidence of uterine pathology by transvaginal ultrasound and hysterosalpingography during the follicular phase.
• Patients with unexplained primary infertility.

Exclusion criteria

• Patients undergoing IVF using other protocols of induction.
• Patients with evidence of uterine pathology by transvaginal ultrasound or hysterosalpingography during the follicular phase.
• Other causes of infertility rather than unexplained factor.
• Unexplained poor responders during the pending ICSI cycle.
• Patients with abnormal findings at hysteroscopy.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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680 participants in 2 patient groups

Group Undergoing Hysterosopy

Experimental group

Description:

This group will include 340 women with unexplained primary infertility undergoing their first trial of IVF/ICSI (intracytoplasmic sperm injection). This group will undergo hysteroscopy in the mid luteal phase of the proceeding cycle.

Treatment:

Procedure: Hysteroscopy

Device: Hysteroscope

Group With No intervention

No Intervention group

Description:

This group will include 340 women with unexplained primary infertility they will undergo their first trial of IVF/ICSI (intracytoplasmic sperm injection) without hysteroscopy in the mid Luteal phase of the proceeding cycle.