Patients' Preference for Subcutaneous or Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles

NCT03181685 | Terminated Phase 4

• 1 other identifier: Andros Day Surgery Clinic
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, controlled, prospective, crossover, open-label, two-treatments, two-period trial aimed to evaluate the preference expressed by the patient concerning the subcutaneous administration of progesterone versus the vaginal one. The couples, scheduled for performing 2 In Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) cycles will be randomized to receive, as luteal phase supplementation, Pleyris 25 milligram (mg) (a single subcutaneous administration per day) or Prometrium 200 mg (3 vaginal administrations per day).

Conditions

Infertility; In Vitro Fertilization

Keywords

Progesterone supplementation; IVF; Preference expressed by the patient

Outcome Measures

Primary Outcomes (1)

• Surveys for testing the satisfaction

  Patient's level of satisfaction will be measured as score on 5-point likert scale + 2 qualitative response

  Single administration at the end of each treatment cycle (an average of 28 days)

Secondary Outcomes (1)

• Semantic Differential Scale

  Single administration at the end of two treatment cycles (an average of 130 days)

Study Arms (2)

Treatment S (Subcutaneous)

ACTIVE COMPARATOR

Progesterone 25 mg subcutaneous (a single administration per day) from the day of oocyte retrieval. Controlled ovarian stimulation (COS) will be performed with recombinant FSH and cetrorelix acetate.

Drug: Progesterone 25 MG subcutaneous; Drug: recombinant FSH; Drug: Cetrorelix Acetate

Treatment V (Vaginal)

ACTIVE COMPARATOR

Micronized progesterone 200 mg (3 vaginal administrations per day) from the day of oocyte retrieval. Controlled ovarian stimulation (COS) will be performed with recombinant FSH and cetrorelix acetate.

Drug: Micronized progesterone 200 MG; Drug: recombinant FSH; Drug: Cetrorelix Acetate

Interventions

Progesterone 25 MG subcutaneous DRUG

A single subcutaneous administration per day from the day of oocyte retrieval

Also known as: Pleyris

Treatment S (Subcutaneous)

Micronized progesterone 200 MG DRUG

3 vaginal administrations per day from the day of oocyte retrieval

Also known as: Prometrium

Treatment V (Vaginal)

recombinant FSH DRUG

Controlled ovarian stimulation (COS)

Also known as: Gonal-f

Treatment S (Subcutaneous); Treatment V (Vaginal)

Cetrorelix Acetate DRUG

Inhibition of Luteinizing Hormone (LH) premature surge during COS

Also known as: Cetrotide

Treatment S (Subcutaneous); Treatment V (Vaginal)

Eligibility Criteria

• Age: 18 Years - 44 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• first IVF/ICSI attempt (at the enrolment), regular menstrual cycles (25-33 days), controlled ovarian stimulation performed with Gonadotropin Releasing Hormone (GnRH) antagonists and gonadotrophins (recombinant FSH)

You may not qualify if:

• systemic diseases, chronic medical therapies, pregnancy in one of the IVF/ICSI cycles, embryo "freeze all" strategy in one of the IVF/ICSI cycles for preventing Ovarian Hyperstimulation Syndrome (OHSS)

Sponsors & Collaborators

• Andros Day Surgery Clinic: lead

Study Sites (1)

ANDROS Day Surgery Clinic, Reproductive Medicine Unit

Palermo, 90144, Italy

Location

Related Publications (3)

• Beltsos AN, Sanchez MD, Doody KJ, Bush MR, Domar AD, Collins MG. Patients' administration preferences: progesterone vaginal insert (Endometrin(R)) compared to intramuscular progesterone for Luteal phase support. Reprod Health. 2014 Nov 11;11:78. doi: 10.1186/1742-4755-11-78.

  PMID: 25385669 BACKGROUND

• van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2015 Jul 7;2015(7):CD009154. doi: 10.1002/14651858.CD009154.pub3.

  PMID: 26148507 BACKGROUND

• Yanushpolsky E, Hurwitz S, Greenberg L, Racowsky C, Hornstein M. Crinone vaginal gel is equally effective and better tolerated than intramuscular progesterone for luteal phase support in in vitro fertilization-embryo transfer cycles: a prospective randomized study. Fertil Steril. 2010 Dec;94(7):2596-9. doi: 10.1016/j.fertnstert.2010.02.033. Epub 2010 Mar 27.

  PMID: 20347079 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Progesterone; Injections, Subcutaneous; follitropin alfa; cetrorelix

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Adolfo Allegra, MD

  Andros Day Surgery Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is randomized, controlled, prospective, crossover, open-label, two-treatments, two-period trial

Study Record Dates

• First Submitted: May 31, 2017
• First Posted: June 9, 2017
• Study Start: December 20, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)