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

Infertility Clinical Trial

Official title:

Subcutaneous Versus Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles: Which is the Preference Expressed by the Patients?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03181685
• Other study ID #: Andros Day Surgery Clinic
• Status: Terminated
• Phase: Phase 4
• Start date: December 20, 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Andros Day Surgery Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Each participant will receive both treatments. During the first IVF/ICSI cycle, the luteal phase will be supplemented with subcutaneous progesterone (S) or vaginal progesterone (V). At the end of the cycle (on the day of beta-hCG), a survey for determining the level of satisfaction will be administered and filled in by the patient during the waiting time and always before the knowledge of the result. This practical organization allows the elimination of emotional biases correlated with the outcome. In case of a negative beta-hCG, the patient will be scheduled for a second IVF/ICSI cycle after a washout (W) period (between 2 and 6 months). In the second cycle, the patient will undergo, during the luteal phase, the opposite treatment (V or S). Also in this case, the survey for evaluating the level of satisfaction will be administered on the day of beta-hCG, with the same modalities of the first cycle. The domains of the surveys are focused on facility of the administration, comfort, level of complaint, side effects, overall level of satisfaction.

The sequence S-V or V-S will be randomly assigned (random assignment) with the concealment of the allocation.

In case of a negative beta-hCG also in the second cycle, a post-hoc comparison between the two treatments will be carried out through a Semantic Differential Scale, in the "follow-up" phase.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

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)

Exclusion Criteria:

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)

Related Conditions & MeSH terms

• In Vitro Fertilization
• Infertility

Intervention

Drug:
• Progesterone 25 MG subcutaneous
A single subcutaneous administration per day from the day of oocyte retrieval
• Micronized progesterone 200 MG
3 vaginal administrations per day from the day of oocyte retrieval
• recombinant FSH
Controlled ovarian stimulation (COS)
• Cetrorelix Acetate
Inhibition of Luteinizing Hormone (LH) premature surge during COS

Locations

Country	Name	City	State
Italy	ANDROS Day Surgery Clinic, Reproductive Medicine Unit	Palermo

Sponsors (1)

Lead Sponsor	Collaborator
Andros Day Surgery Clinic

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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

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;(7):CD009154. doi: 10.1002/14651858.CD009154.pub3. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Semantic Differential Scale	Patient's preference of treatment measured on a 7-point likert scale	Single administration at the end of two treatment cycles (an average of 130 days)