## Protocol Section
### Identification Module
**NCT ID:** NCT06413771

**Brief Title:** Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation in IUI Cycles

**Official Title:** Comparison of Two Ovarian Stimulation Strategies in Intrauterine Insemination Cycles of Couples With Unexplained Infertility; Only Gonadotropin Vs. Letrozole Combined Gonadotropin Stimulation. A Randomized Controlled Trial.

#### Organization Study ID Info
**ID:** 2022-4/39
#### Organization
**Class:** OTHER
**Full Name:** Uludag University
### Status Module
#### Completion Date
**Date:** 2024-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-01-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-09
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Uludag University

#### Responsible Party

**Investigator Affiliation:** Uludag University

**Investigator Full Name:** GÜRKAN UNCU,PROF. MD

**Investigator Title:** Prof.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The present randomized controlled study aims to investigate the effectiveness of a combined regimen of letrozole and gonadotropin with dose adjustments based on body mass index (BMI) compared to a conventional only gonadotropin regimen in intrauterine insemination (IUI) cycles for couples experiencing unexplained infertility. The study was conducted at a tertiary university hospital's Assisted Reproductive Technologies (ART) center from January 2023 to January 2024. Couples with unexplained infertility were enrolled based on comprehensive assessments, and randomization was performed based on national ID (odd or even). The Conventional Only Gonadotropin (COG) group received recombinant FSH based on body mass index (BMI), while the Combined Letrozole-Gonadotropin (CLG) group received letrozole followed by gonadotropin with dose adjustments based on BMI. Ovulation induction and IUI were performed according to standard protocols. Clinical outcomes, gonadotropin consumption, and pregnancy rates were compared between groups. Among 317 IUI cycles, 131 couples with unexplained infertility were randomized (CLG: 61, COG: 70). Demographic parameters were similar between groups. The CLG group had lower daily gonadotropin doses (67 ± 18 IU/D vs. 76 ± 11 IU/d, p=0.01) and total gonadotropin consumption (750 IU vs. 825 IU, p=0.01) with comparable ovulation and clinical pregnancy rates. The COG group exhibited higher multiple pregnancy rates, although not statistically significant (CLG vs. COG; 1/61 vs. 3/70, p=0.4). The study suggests that the combined letrozole and gonadotropin regimen with BMI-based dose adjustments in IUI cycles for unexplained infertility is associated with reduced gonadotropin consumption and potentially lower multiple pregnancy rates.

### Conditions Module

**Conditions:**

- Infertility Unexplained

**Keywords:**

- unexplained infertility

- letrozole

- gonadotropin

- intrauterine insemination

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Patients were divided into two study arms based on the initial digits of their national IDs by ART nurses. Importantly, the IVF clinicians remained blinded to the patients' grouping throughout the study.

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 131

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The Conventional Only Gonadotropin (COG) group received recombinant FSH based on body mass index (BMI)

**Intervention Names:**

- Drug: Gonadotropin

**Label:** Conventional Only Gonadotropin

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The combined Letrozole-Gonadotropin (CLG) group received letrozole followed by gonadotropin with dose adjustments based on BMI.

**Intervention Names:**

- Drug: Letrozole 2.5mg

**Label:** Combined Letrozole-Gonadotropin group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Combined Letrozole-Gonadotropin group

**Description:** Letrozole pretreatment during ovarian stimulation with gonadotropins, in intrauterine insemination cycles.

**Name:** Letrozole 2.5mg

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Conventional Only Gonadotropin

**Description:** Ovarian stimulation with gonadotropins, in intrauterine insemination cycles.

**Name:** Gonadotropin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Presence of gestational sac by transvaginal ultrasound

**Measure:** Clinical Pregnancy Rate

**Time Frame:** 6 weeks

#### Secondary Outcomes

**Description:** Presence of multipl gestational sacs by transvaginal ultrasound

**Measure:** Multiple Pregnancy Rate

**Time Frame:** 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Couples with unexplained infertility
* Aged between 18-35

Exclusion Criteria:

* Male factor infertility
* Diminished ovarian reserve
* Patient refusion to participate

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bursa

**Country:** Turkey

**Facility:** Uludag University Faculty of Medicine

**State:** Gorukle

**Zip:** 16085

#### Overall Officials

**Official 1:**

**Affiliation:** Uludag University

**Name:** Gurkan Uncu, Prof.

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Description:** All data generated or analyzed during this study are included in this published article and are available from the corresponding author on reasonable request.

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10290

- Name: Infertility

- Relevance: HIGH

- As Found: Infertility

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007246

- Term: Infertility

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000047072

- Term: Aromatase Inhibitors

- ID: D000065088

- Term: Steroid Synthesis Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000004965

- Term: Estrogen Antagonists

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M1743

- Name: Letrozole

- Relevance: HIGH

- As Found: Visual

- ID: M25769

- Name: Aromatase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M8116

- Name: Estrogens

- Relevance: LOW

- As Found: Unknown

- ID: M8114

- Name: Estrogen Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M30483

- Name: Estrogen Receptor Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000077289

- Term: Letrozole

### Misc Info Module

- Version Holder: 2024-05-31
