NCT05276531

Brief Summary

The invesigators aimed to seperate the patients,which is going to be applied IUI, to two different groups as prospective randomized controlled ;assess the efficacy of the two different way pressurised progesterone by appling intravaginal progesterone to the first group; subcutaneous to the second group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

2 months

First QC Date

March 3, 2022

Last Update Submit

September 8, 2022

Conditions

Progesterone

Keywords

progesteroneiui

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    after iui betahcg levels blood sampling

    day 15

Secondary Outcomes (1)

  • Ongoing pregnancy rate

    Months 3

Study Arms (2)

subcutaneous progesterone

EXPERIMENTAL

PROLUTEX® 25 mg Solution for injection, IBSA Group, Lugano, Switzerland

Drug: subcutaneous progesterone

vaginal progesterone

ACTIVE COMPARATOR

LUTINUS® 100 mg vaginal tablets, Ferring GmbH Wittland/Kiel/Germany

Drug: vaginal progesterone

Interventions

subcutaneous progesteroneDRUG

clinical pregnancy rates

subcutaneous progesterone
vaginal progesteroneDRUG

clinical pregnancy rates

vaginal progesterone

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Absence of follicles larger than 10 mm on basal ultrasound
  • Endometrial thickness less than 5 mm
  • Patients with FSH\<10 IU/ml, E2\<60-80 pg/ml in the blood hormone test performed on the third day of the cycle and patients with antral follicle count above 7 on ultrasound
  • Total motile sperm count greater than 10 million/ml
  • years old female, 18-50 years old male
  • Anovulation, patients diagnosed with unexplained mild male factor infertility
  • Female partners, who's BMI\<25 kg/m²
  • Being voluntarily

You may not qualify if:

  • Other infertility reasons
  • The patients who doesn't meet the criterias
  • Refusing to attend to the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

  • Erdem A, Erdem M, Atmaca S, Guler I. Impact of luteal phase support on pregnancy rates in intrauterine insemination cycles: a prospective randomized study. Fertil Steril. 2009 Jun;91(6):2508-13. doi: 10.1016/j.fertnstert.2008.04.029. Epub 2008 Aug 9.

    PMID: 18692788BACKGROUND

  • Oktem M, Altinkaya SO, Yilmaz SA, Bozkurt N, Erdem M, Erdem A, Gumuslu S. Effect of luteal phase support after ovulation induction and intrauterine insemination. Gynecol Endocrinol. 2014;30(12):909-12. doi: 10.3109/09513590.2014.947567. Epub 2014 Aug 7.

    PMID: 25102275BACKGROUND

  • Maher MA. Luteal phase support may improve pregnancy outcomes during intrauterine insemination cycles. Eur J Obstet Gynecol Reprod Biol. 2011 Jul;157(1):57-62. doi: 10.1016/j.ejogrb.2011.03.022. Epub 2011 Apr 21.

    PMID: 21514032BACKGROUND

  • Ozcan P, Takmaz T. Identification of predictive factors for the probability of pregnancy following ovulation stimulation-intra-uterine insemination cycles in terms of female and male. J Obstet Gynaecol Res. 2021 Mar;47(3):893-899. doi: 10.1111/jog.14594. Epub 2021 Jan 5.

    PMID: 33403758BACKGROUND

  • Keskin M, Aytac R. Does Luteal Phase Support Effect Pregnancy Rates in Intrauterine Insemination Cycles? A Prospective Randomised Controlled Study in a Tertiary Center. Obstet Gynecol Int. 2020 Aug 5;2020:6234070. doi: 10.1155/2020/6234070. eCollection 2020.

    PMID: 32831851BACKGROUND

  • Khosravi D, Taheripanah R, Taheripanah A, Tarighat Monfared V, Hosseini-Zijoud SM. Comparison of oral dydrogesterone with vaginal progesteronefor luteal support in IUI cycles: a randomized clinical trial. Iran J Reprod Med. 2015 Jul;13(7):433-8.

    PMID: 26494991BACKGROUND

  • Green KA, Zolton JR, Schermerhorn SM, Lewis TD, Healy MW, Terry N, DeCherney AH, Hill MJ. Progesterone luteal support after ovulation induction and intrauterine insemination: an updated systematic review and meta-analysis. Fertil Steril. 2017 Apr;107(4):924-933.e5. doi: 10.1016/j.fertnstert.2017.01.011. Epub 2017 Feb 24.

    PMID: 28238492BACKGROUND

Study Officials

  • Gurkan Kiran, MD

    Bezmialem Vakif University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 11, 2022

Study Start

April 1, 2022

Primary Completion

June 1, 2022

Study Completion

September 1, 2022

Last Updated

September 9, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)