Patients' Preference for Subcutaneous or Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Treatment S (Subcutaneous) 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
A single subcutaneous administration per day from the day of oocyte retrieval
Other Names:
Drug: recombinant FSH
Controlled ovarian stimulation (COS)
Other Names:
Drug: Cetrorelix Acetate
Inhibition of Luteinizing Hormone (LH) premature surge during COS
Other Names:
|
| Active Comparator: Treatment V (Vaginal) 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
3 vaginal administrations per day from the day of oocyte retrieval
Other Names:
Drug: recombinant FSH
Controlled ovarian stimulation (COS)
Other Names:
Drug: Cetrorelix Acetate
Inhibition of Luteinizing Hormone (LH) premature surge during COS
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Surveys for testing the satisfaction [Single administration at the end of each treatment cycle (an average of 28 days)]
Patient's level of satisfaction will be measured as score on 5-point likert scale + 2 qualitative response
Secondary Outcome Measures
- Semantic Differential Scale [Single administration at the end of two treatment cycles (an average of 130 days)]
Patient's preference of treatment measured on a 7-point likert scale
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ANDROS Day Surgery Clinic, Reproductive Medicine Unit | Palermo | Italy | 90144 |
Sponsors and Collaborators
- Andros Day Surgery Clinic
Investigators
- Principal Investigator: Adolfo Allegra, MD, Andros Day Surgery Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- Andros Day Surgery Clinic