---
title: Ejaculatory Abstinence in IUI Cycles
nct_id: NCT04361292
overall_status: COMPLETED
phase: NA
sponsor: Pamukkale University
study_type: INTERVENTIONAL
primary_condition: Infertility
countries: Turkey (Türkiye)
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04361292.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04361292"
ct_last_update_post_date: 2020-04-27
last_seen_at: "2026-05-12T06:33:05.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Ejaculatory Abstinence in IUI Cycles

**Official Title:** Effect of Ejaculatory Abstinence Period on Sperm DNA Fragmentation and Pregnancy Outcome of Intrauterine Insemination Cycles: A Prospective Randomized Study

**NCT ID:** [NCT04361292](https://clinicaltrials.gov/study/NCT04361292)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Pamukkale University
- **Conditions:** Infertility, Spermatozoa, Reproductive Disorder
- **Start Date:** 2019-01-01
- **Completion Date:** 2020-02-29
- **CT.gov Last Update:** 2020-04-27

## Brief Summary

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.

## Detailed Description

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

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 40 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **Group A: one day abstinence period** (ACTIVE_COMPARATOR) — Patients allocated into group A had an ejaculatory abstinence period of one day
- **Group B: three days abstinence period** (ACTIVE_COMPARATOR) — Patients allocated into group B had an ejaculatory abstinence period of three days

## Interventions

- **INTRAUTERINE INSEMINATION** (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.

## Primary Outcomes

- **pregnancy rate** _(time frame: The pregnancy test was done 14 days after intrauterine insemination. If the test was positive, transvaginal ultrasonography was performed at 6-7 weeks of gestation.)_ — The presence of one or more gestational sacs on transvaginal ultrasonography was described as clinical pregnancy.

## Secondary Outcomes

- **Sperm DNA fragmentation percentage** _(time frame: On the day of IUI, semen samples were obtained and the sperm DNA fragmentation was measured by the TUNEL method in the inseminated sperm.)_

## Locations (1)

- Pamukkale University Faculty of Medicine, Obstetrics and Gynecology Department, Infertility Center, Denizli, Turkey (Türkiye)

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pamukkale university faculty of medicine, obstetrics and gynecology department, infertility center|denizli||turkey (türkiye)` — added _(2026-05-12)_

---

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