Ejaculatory Abstinence in IUI 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

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-02-29

Brief Summary

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Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The aim of this study was to report the effect of ejaculatory abstinence on sperm DNA fragmentation and pregnancy rates in IUI cycles, as well as the correlation between the two.

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Detailed Description

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Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The fact that IUI is less expensive, less invasive, and easier to perform than other assisted reproductive techniques makes it the first-line treatment option in infertility treatments. Several studies have been published over the past few years examining the relationship between sperm DNA fragmentation and IUI outcome. The optimal period for ejaculatory abstinence before the semen sample is a controversial issue in the literature. There are only two retrospective studies examining the relationship between the ejaculatory abstinence period and pregnancy rates after IUI.

Several studies suggested performing IUI with sperm samples obtained in a shorter abstinence period than recommended by WHO. However, there isn't enough research on this issue in the literature. Moreover, there is no specific prospective clinical research examining the relationship of ejaculatory abstinence period and sperm DNA fragmentation in IUI cycles. The aim of this study was to report the effect of ejaculatory abstinence on sperm DNA fragmentation and pregnancy rates in IUI cycles, as well as the correlation between the two

Conditions

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Infertility Spermatozoa Reproductive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One hundred twenty eligible couples were prospectively randomized into two groups on the second day of the cycle just before starting the treatment protocol. Randomization was performed according to a computer-generated random number list at a ratio of 1:1. From the randomization list, an independent secretary who was blind to patients' identities applied the allocation in consecutive order. Patients allocated into group A, had an ejaculatory abstinence period of one day, whereas patients allocated into group B had an ejaculatory abstinence period of three days.

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

From the randomization list, an independent secretary who was blind to patients' identities applied the allocation in consecutive order. Patients allocated into group A, and group B. Care provider and investigator were blind to patient groups. Participants were informed about the timing of abstinence intervals, but they did not know which groups they were allocated to.

Study Groups

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Group A: one day abstinence period

Patients allocated into group A had an ejaculatory abstinence period of one day

Group Type ACTIVE_COMPARATOR

INTRAUTERINE INSEMINATION

Intervention Type PROCEDURE

Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The fact that IUI is less expensive, less invasive, and easier to perform than other assisted reproductive techniques makes it the first-line treatment option in infertility treatments. Sperm that have been washed and concentrated are placed directly into the uterus around the time of ovulation. All patients had ovulation induction with gonadotropins and ovulation was triggered by recombinant hcg.

Group B: three days abstinence period

Patients allocated into group B had an ejaculatory abstinence period of three days

Group Type ACTIVE_COMPARATOR

INTRAUTERINE INSEMINATION

Intervention Type PROCEDURE

Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The fact that IUI is less expensive, less invasive, and easier to perform than other assisted reproductive techniques makes it the first-line treatment option in infertility treatments. Sperm that have been washed and concentrated are placed directly into the uterus around the time of ovulation. All patients had ovulation induction with gonadotropins and ovulation was triggered by recombinant hcg.

Interventions

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INTRAUTERINE INSEMINATION

Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The fact that IUI is less expensive, less invasive, and easier to perform than other assisted reproductive techniques makes it the first-line treatment option in infertility treatments. Sperm that have been washed and concentrated are placed directly into the uterus around the time of ovulation. All patients had ovulation induction with gonadotropins and ovulation was triggered by recombinant hcg.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Infertility for more than 12 months
* Diagnosed as unexplained infertility
* Female age between 20 and 40 years
* Regular menstrual cycles
* Mid-luteal progesterone levels of \>3 ng/ml
* Basal FSH \<12 mIU/ml, AMH \>1ng/ml
* Body mass index (BMI) 19-35 kg/m2
* No pelvic pathology documented by transvaginal ultrasound and bilateral tubal patency diagnosed by hysterosalpingography
* Normal semen parameters according to WHO criteria

Exclusion Criteria

* Any endocrine and pelvic pathology
* PCOS (polycystic ovarian syndrome)
* Known endometriosis history
* Prior pelvic surgery
* Persistent ovarian cysts.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes